Capsule Quality Control – SOP Guide for Pharma https://www.pharmasop.in The Ultimate Resource for Pharmaceutical SOPs and Best Practices Wed, 02 Apr 2025 10:46:00 +0000 en-US hourly 1 https://wordpress.org/?v=6.7.2 Capsule: SOP for Cleaning Capsule Filling Machines After Batch Completion – V 2.0 https://www.pharmasop.in/capsule-sop-for-cleaning-capsule-filling-machines-after-batch-completion-v-2-0/ Wed, 02 Apr 2025 10:46:00 +0000 https://www.pharmasop.in/?p=9485 Read More “Capsule: SOP for Cleaning Capsule Filling Machines After Batch Completion – V 2.0” »

]]> Capsule: SOP for Cleaning Capsule Filling Machines After Batch Completion – V 2.0

Standard Operating Procedure for Cleaning Capsule Filling Machines After Batch Completion

Department Capsule Manufacturing
SOP No. SOP/CM/111/2025
Supersedes SOP/CM/111/2022
Page No. Page 1 of 6
Issue Date 01/02/2025
Effective Date 05/02/2025
Review Date 01/02/2026

1. Purpose

The purpose of this SOP is to outline the procedures for cleaning capsule filling machines after the completion of a production batch. Effective cleaning ensures that cross-contamination is prevented, machinery operates efficiently, and compliance with Good Manufacturing Practices (GMP) is maintained.

2. Scope

This SOP applies to all capsule filling machines in the production department. It covers cleaning after the completion of each batch to ensure the equipment is thoroughly cleaned before the next batch is produced.

3. Responsibilities

  • Production Operators: Responsible for carrying out the cleaning procedure as outlined in this SOP, ensuring that all equipment components are thoroughly cleaned and documented.
  • Maintenance Team: Ensures that any mechanical components that need disassembly for cleaning are properly reassembled and functioning.
  • Quality Control (QC) Team: Responsible for verifying that the cleaning process has been completed satisfactorily and that there is no residual contamination left in the equipment.
  • Production Supervisor: Oversees the cleaning process, ensures that it is carried out according to the SOP, and ensures that the equipment is fit for the next batch.

4. Accountability

The Capsule Manufacturing Supervisor is accountable for ensuring that the capsule filling machines are properly cleaned according to this SOP and that the cleaning process is documented and reviewed. The Maintenance Team is responsible for ensuring that any necessary repairs or maintenance are completed during cleaning. The QA Manager is responsible for confirming that the cleaning procedure meets all GMP standards.

5. Procedure

5.1 Preparation for Cleaning

Before beginning the cleaning process, the following preparations should be made:

  1. Ensure the Machine is Stopped

    1. Ensure that the machine is turned off and that the power is disconnected to avoid any accidents during cleaning.
  2. Gather Cleaning Materials

    1. Collect all necessary cleaning materials, including water, approved cleaning agents, brushes, lint-free cloths, and any required PPE (Personal Protective Equipment).
    2. Ensure that cleaning agents are non-corrosive and safe for the capsule filling machine components.
  3. Prepare Cleaning Log

    1. Prepare the Cleaning Log (Annexure-1) where all cleaning actions and observations will be recorded.

5.2 Disassembly of Capsule Filling Machine

If required, the following steps should be followed to disassemble the parts of the capsule filling machine that need cleaning:

  1. Remove All Product Contact Parts

    1. Remove all parts that come into direct contact with the capsule fill, such as the dosing discs, fill plates, hopper, and any tools or feeders.
  2. Ensure Proper Labeling of Removed Parts

    1. Label all disassembled parts clearly to ensure that they are reassembled in the correct order after cleaning.
  3. Place Parts in Appropriate Cleaning Stations

    1. Place all disassembled parts in designated cleaning stations to ensure that the cleaning process is carried out effectively.

5.3 Cleaning Process

Follow these steps to clean the capsule filling machine and its components:

  1. Clean All Components

    1. Use a non-abrasive brush to remove any residual powder or product from the components. Pay special attention to areas that are difficult to reach, such as the hopper and dosing mechanism.
    2. Wipe all parts with a lint-free cloth to remove any remaining dust, powder, or cleaning solution.
  2. Rinse with Water

    1. Rinse all components with warm water to remove any cleaning solution residues.
    2. Ensure that all parts are thoroughly rinsed and there are no traces of cleaning chemicals left on any surfaces.
  3. Use Approved Cleaning Agents

    1. Apply approved cleaning agents to remove any sticky or residual substances that cannot be removed with water alone. Follow the manufacturer’s instructions on the use of cleaning agents.
    2. Ensure that the cleaning agents used are compatible with the machine parts and do not cause damage or degradation of the material.
  4. Disinfect All Components

    1. If required, disinfect the components after cleaning to prevent microbial contamination.

5.4 Drying and Reassembly

After cleaning, the components must be dried and reassembled:

  1. Dry All Components

    1. Ensure that all components are dried thoroughly using a clean, dry, lint-free cloth. Allow components to air dry if necessary.
  2. Reassemble the Machine

    1. Once all components are dry, carefully reassemble the capsule filling machine, following the labels placed during disassembly.

5.5 Post-Cleaning Inspection

After the cleaning process, the following checks should be performed:

  1. Inspect for Any Residues

    1. Visually inspect the machine for any residues of product or cleaning solution. If any residues are found, repeat the cleaning process as necessary.
  2. Check the Machine for Proper Assembly

    1. Ensure that all parts are correctly reassembled and secured before starting the machine.
  3. Run a Test Batch

    1. Run a small test batch to verify that the machine is functioning properly and that no contamination remains from the previous batch.

5.6 Documentation

Ensure all actions related to cleaning are documented properly:

  1. Record Cleaning Details

    1. Document the details of the cleaning process, including date, time, operator, and any issues or deviations in the Cleaning Log (Annexure-1).
  2. Record Inspection Results

    1. Record the results of the post-cleaning inspection in the Equipment Inspection Log (Annexure-2).

6. Abbreviations

  • SOP: Standard Operating Procedure
  • GMP: Good Manufacturing Practice
  • QC: Quality Control
  • QA: Quality Assurance
  • PPE: Personal Protective Equipment

7. Documents

  1. Cleaning Log (Annexure-1)
  2. Equipment Inspection Log (Annexure-2)
  3. Maintenance Log (Annexure-3)

8. References

  • USP <1163> – Pharmaceutical Dosage Forms: Capsules
  • FDA Guidelines for Capsule Manufacturing
  • Good Manufacturing Practice (GMP) Guidelines

9. SOP Version

Version: 2.0

10. Approval Section

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Continuing from SOP 111: SOP for Cleaning Capsule Filling Machines After Batch Completion:

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Prepared By Checked By Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Cleaning Log

Batch ID Cleaning Date Operator Cleaning Action Comments
Batch 001 02/02/2025 John Doe Disassembled and cleaned capsule filling machine components No residue found

Annexure-2: Equipment Inspection Log

Equipment ID Inspection Date Inspection Results Operator Next Maintenance Due
Filling Machine 001 02/02/2025 No defects found, machine fully operational Jane Smith 02/02/2026

Annexure-3: Maintenance Log

Equipment ID Maintenance Date Maintenance Activity Performed By Next Maintenance Due
Filling Machine 001 02/02/2025 Recalibrated filling system and cleaned internal components John Doe 02/02/2026

Revision History:

Revision Date Revision No. Revision Details Reason for Revision Approved By
01/01/2024 1.0 Initial version New SOP Creation QA Head
01/02/2025 2.0 Updated cleaning procedure and added inspection details Improved accuracy and compliance QA Head
]]> Capsule: SOP for Processing Overages in Capsule Formulations – V 2.0 https://www.pharmasop.in/capsule-sop-for-processing-overages-in-capsule-formulations-v-2-0/ Wed, 02 Apr 2025 03:56:00 +0000 https://www.pharmasop.in/?p=9484 Read More “Capsule: SOP for Processing Overages in Capsule Formulations – V 2.0” »

]]> Capsule: SOP for Processing Overages in Capsule Formulations – V 2.0

Standard Operating Procedure for Processing Overages in Capsule Formulations

Department Capsule Manufacturing
SOP No. SOP/CM/110/2025
Supersedes SOP/CM/110/2022
Page No. Page 1 of 6
Issue Date 01/02/2025
Effective Date 05/02/2025
Review Date 01/02/2026

1. Purpose

The purpose of this SOP is to define the procedure for processing overages in capsule formulations. Overages are typically added to compensate for losses during the manufacturing process, ensuring that each capsule contains the required amount of active pharmaceutical ingredient (API). This SOP ensures that overages are processed accurately, safely, and in compliance with GMP standards.

2. Scope

This SOP applies to all formulations in capsule manufacturing that involve the addition of overages, including both hard and soft gelatin capsules. It covers the calculation, preparation, and processing of overages during the capsule filling process.

3. Responsibilities

  • Production Operators: Responsible for accurately preparing and processing the overage according to the specified formulation. They must ensure that the correct overage amount is added during production.
  • Quality Control (QC) Team: Responsible for verifying the overage content, ensuring that it complies with the required specifications, and performing checks on the final product.
  • Quality Assurance (QA) Team: Ensures compliance with SOP, verifies documentation, and reviews any deviations or discrepancies related to overage processing.
  • Production Supervisor: Oversees the entire process, ensures correct procedures are followed, and coordinates between production, QC, and QA teams.

4. Accountability

The Capsule Manufacturing Supervisor is accountable for ensuring that the overage process is executed as per this SOP and in compliance with regulatory standards. The QA Manager is responsible for reviewing and approving the overage processing procedure, ensuring that the final product meets the required specifications.

5. Procedure

5.1 Calculating the Overage

Overages are typically calculated based on the estimated loss during manufacturing and the required API dosage per capsule. The following steps must be followed:

  1. Determine the Required Overage Percentage

    1. Consult the product formulation sheet to determine the overage percentage required for the specific formulation.
    2. Common overage percentages range from 2% to 5% but may vary depending on the formulation and manufacturing process.
  2. Calculate the Total Amount of Active Ingredient

    1. Calculate the total required API based on the number of capsules to be produced and the required dosage per capsule.
    2. Apply the overage percentage to the total API required to determine the additional quantity to be added to the batch.
  3. Calculate the Total Weight of Ingredients

    1. Calculate the total weight of the formulation ingredients, including the active ingredient (API), excipients, and overage.
    2. Ensure that the final batch weight accounts for the overage to prevent under-dosing.

5.2 Preparing the Overage

Once the overage amount is calculated, proceed with preparing the overage for inclusion in the capsule filling process:

  1. Prepare API and Excipients

    1. Weigh the required amount of API and excipients using a calibrated balance, ensuring accuracy within the required tolerance limits.
    2. Prepare the ingredients as specified in the formulation sheet, mixing them in the correct proportions, including the calculated overage.
  2. Record the Preparation

    1. Document the weights of all ingredients, including the overage, in the Batch Record (Annexure-1). Ensure that any changes made during the preparation are also recorded.
    2. Ensure that the preparation log includes the batch number, date, and names of personnel involved in preparing the overage.

5.3 Processing the Overage During Capsule Filling

During the capsule filling process, the overage is added to the capsule formulation to compensate for losses. The following steps should be followed:

  1. Check Capsule-Filling Machine Settings

    1. Ensure that the capsule filling machine is calibrated to accommodate the overage amount and that it can handle any increase in the total weight of the capsule contents.
    2. Verify that the fill weight system is calibrated, ensuring that the added overage does not lead to excessive variation in capsule weight.
  2. Add the Overage to the Capsule Filler

    1. Ensure the overage is added to the capsule filling system as per the calculated amount. This may require adding the overage in small portions to ensure uniform distribution throughout the batch.
    2. Record the addition of overage in the production log.
  3. Monitor Capsule Weight

    1. After adding the overage, perform weight checks on randomly selected capsules throughout the production run to ensure that the weight is within acceptable limits.
    2. If any capsules fall outside the acceptable weight range, investigate and correct the filling process.

5.4 Quality Control and Final Checks

Quality control checks must be conducted to verify that the overage was correctly processed and that the final product meets specifications:

  1. Capsule Weight Testing

    1. Test a random sample of filled capsules to verify that the weight is within the specified range.
    2. Ensure that the weight consistency is maintained across the entire batch, accounting for the overage.
  2. Uniformity of Content Testing

    1. Perform content uniformity testing to ensure that the amount of API in the capsules is consistent and within the required limits.
  3. Final Product Inspection

    1. Inspect the final batch for any visual defects, such as cracks, leaks, or incomplete seals. If any defects are found, initiate a corrective action as necessary.

5.5 Documentation and Reporting

Proper documentation of the overage processing procedure is essential for traceability and regulatory compliance:

  1. Record All Data

    1. Record all relevant data, including overage calculations, preparation logs, batch records, and QC testing results, in the appropriate production logs (Annexure-1, Annexure-2, etc.).
  2. Report Deviations

    1. Any deviation from the standard overage processing procedure must be documented in the Deviation Log (Annexure-3), with corrective actions noted and reviewed by the QA team.

6. Abbreviations

  • SOP: Standard Operating Procedure
  • GMP: Good Manufacturing Practice
  • QC: Quality Control
  • QA: Quality Assurance
  • API: Active Pharmaceutical Ingredient

7. Documents

  1. Batch Record (Annexure-1)
  2. Capsule Weight and Fill Volume Log (Annexure-2)
  3. Deviation Log (Annexure-3)
  4. Maintenance Log (Annexure-4)

8. References

  • USP <1163> – Pharmaceutical Dosage Forms: Capsules
  • FDA Guidelines for Capsule Manufacturing
  • Good Manufacturing Practice (GMP) Guidelines

9. SOP Version

Version: 2.0

10. Approval Section

Prepared By Checked By Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Batch Record

Batch ID Gelatin Composition API Quantity Overage Percentage Added Overage Operator Approval Status
Batch 001 Standard 500mg 5% 25mg Jane Smith Approved

Annexure-2: Capsule Weight and Fill Volume Log

Sample ID Capsule Weight (mg) Fill Volume (mL) Pass/Fail Operator
Sample 001 550 1.2 Pass John Doe

Annexure-3: Deviation Log

Deviation ID Batch ID Description Corrective Action Operator Approval Status
DEV-001 Batch 001 Overage addition error Recalculated overage and adjusted dosage Jane Smith Approved

Annexure-4: Maintenance Log

Annexure-4: Maintenance Log
Equipment ID Maintenance Date Maintenance Activity Performed By Next Maintenance Due
Filling Machine 001 02/02/2025 Recalibrated filling system to accommodate overage John Doe 02/02/2026

Revision History:

Revision Date Revision No. Revision Details Reason for Revision Approved By
01/01/2024 1.0 Initial version New SOP Creation QA Head
01/02/2025 2.0 Added detailed corrective actions for overage discrepancies Improved documentation and accuracy QA Head
]]> Capsule: SOP for Handling Capsule Variability in High-Speed Machines – V 2.0 https://www.pharmasop.in/capsule-sop-for-handling-capsule-variability-in-high-speed-machines-v-2-0/ Tue, 01 Apr 2025 21:06:00 +0000 https://www.pharmasop.in/?p=9483 Read More “Capsule: SOP for Handling Capsule Variability in High-Speed Machines – V 2.0” »

]]> Capsule: SOP for Handling Capsule Variability in High-Speed Machines – V 2.0

Standard Operating Procedure for Handling Capsule Variability in High-Speed Machines

Department Capsule Manufacturing
SOP No. SOP/CM/109/2025
Supersedes SOP/CM/109/2022
Page No. Page 1 of 6
Issue Date 01/02/2025
Effective Date 05/02/2025
Review Date 01/02/2026

1. Purpose

The purpose of this SOP is to define the procedure for handling capsule variability in high-speed machines during the encapsulation process. Variability in capsule weight, fill volume, or sealing integrity can occur at high production speeds. This SOP outlines how to identify, mitigate, and control such variability to ensure consistent product quality.

2. Scope

This SOP applies to all high-speed capsule filling machines used in the manufacturing process. It covers the identification, monitoring, and correction of variability in capsule characteristics such as weight, fill volume, and sealing quality.

3. Responsibilities

  • Production Operators: Responsible for monitoring and reporting variability during production. Ensure adjustments are made based on specifications and document all actions.
  • Maintenance Team: Responsible for ensuring the machine is running at optimal performance and addressing any mechanical issues that could contribute to variability.
  • Quality Control (QC) Team: Responsible for checking capsule quality (weight, fill volume, and seal) at regular intervals and ensuring compliance with established specifications.
  • Quality Assurance (QA) Team: Ensures that the overall process complies with GMP standards and reviews any corrective actions taken to address variability.
  • Production Supervisor: Oversees the process and ensures that all team members are following the SOP. Takes necessary actions in the event of recurring variability issues.

4. Accountability

The Capsule Manufacturing Supervisor is accountable for ensuring that all operators follow this SOP for monitoring and controlling capsule variability. The Maintenance Manager is responsible for ensuring that the equipment is functioning correctly. The QA Manager ensures that all deviations are addressed according to company policies and regulatory standards.

5. Procedure

5.1 Identifying Capsule Variability

Capsule variability is identified through regular inspections during production. The following steps must be followed:

  1. Monitor Capsule Weight

    1. Weigh random samples of capsules at regular intervals during production. Ensure that the capsules meet the weight specifications.
    2. If the weight of the sample is outside the acceptable range, investigate the possible cause and take corrective action.
  2. Monitor Capsule Fill Volume

    1. Inspect the fill volume of randomly selected capsules. Use appropriate equipment (e.g., automated volume measurement tools) to ensure consistency in fill volume.
    2. Adjust the filling system if the fill volume deviates from the target specification.
  3. Monitor Capsule Sealing

    1. Inspect capsule sealing quality by visually checking for cracks, leaks, or incomplete seals.
    2. If sealing variability is observed, check the machine for malfunctions such as pressure inconsistencies or improper sealing temperature.

5.2 Correcting Capsule Variability

If variability is detected, take the following corrective actions:

  1. Adjust Machine Settings

    1. If capsule weight or fill volume is inconsistent, adjust the machine settings such as filling volume, powder flow rate, or capsule alignment.
    2. For sealing issues, check the machine’s temperature and pressure settings, and make adjustments to achieve consistent sealing quality.
  2. Check and Replace Consumables

    1. Inspect the capsule filling material, such as powders or liquids, for consistency. If inconsistencies are found, replace or recondition the material before continuing production.
    2. Inspect sealing equipment, including sealing bands and gaskets, for wear. Replace any worn-out components to restore proper function.
  3. Perform Equipment Maintenance

    1. If variability persists despite adjustments, schedule a maintenance check. Inspect critical components, including the filler, seals, and capsule transport system, for malfunction or wear.
    2. Perform cleaning and calibration of the equipment if necessary.

5.3 Monitoring and Documentation

Once corrective actions are taken, it is important to document and monitor the effectiveness of the changes:

  1. Record Variability Data

    1. Record the details of the variability event, corrective actions taken, and the results of the follow-up tests in the Variability Log (Annexure-1).
  2. Re-sample and Re-test

    1. After making corrections, re-sample and re-test the capsules to ensure that the variability has been addressed. Continue monitoring at regular intervals to ensure consistency in product quality.

5.4 Resuming Production

After ensuring that capsule variability has been corrected, production can resume:

  1. QA Review

    1. Have the QA team review all records, including machine settings, testing results, and corrective actions. Verify that the final product meets the required specifications.
  2. Production Resumption

    1. If everything meets the required standards, resume capsule production and continue to monitor the machine’s performance closely during the next few production runs.

6. Abbreviations

  • SOP: Standard Operating Procedure
  • GMP: Good Manufacturing Practice
  • QC: Quality Control
  • QA: Quality Assurance

7. Documents

  1. Variability Log (Annexure-1)
  2. Capsule Weight and Fill Volume Log (Annexure-2)
  3. Deviation Log (Annexure-3)
  4. Maintenance Log (Annexure-4)

8. References

  • USP <1163> – Pharmaceutical Dosage Forms: Capsules
  • FDA Guidelines for Capsule Manufacturing
  • Good Manufacturing Practice (GMP) Guidelines

9. SOP Version

Version: 2.0

10. Approval Section

Prepared By Checked By Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Variability Log

Event ID Batch ID Type of Variability Corrective Action Operator Approval Status
VAR-001 Batch 001 Weight Inconsistency Adjusted fill volume John Doe Approved

Annexure-2: Capsule Weight and Fill Volume Log

Sample ID Capsule Weight (mg) Fill Volume (mL) Pass/Fail Operator
Sample 001 500 1.2 Pass Jane Smith

Annexure-3: Deviation Log

Deviation ID Batch ID Description Corrective Action Operator Approval Status
DEV-001 Batch 001 Irregular capsule weight Recalibrated the machine John Doe Approved

Annexure-4: Maintenance Log

Equipment ID Maintenance Date Maintenance Activity Performed By Next Maintenance Due
Filling Machine 001 02/02/2025 Recalibrated filling system Jane Smith 02/02/2026

Revision History:

Revision Date Revision No. Revision Details Reason for Revision Approved By
01/01/2024 1.0 Initial version New SOP Creation QA Head
01/02/2025 2.0 Updated troubleshooting and corrective actions Improved accuracy and reduced errors QA Head
]]> Capsule: SOP for Addressing Equipment Malfunctions During Encapsulation – V 2.0 https://www.pharmasop.in/capsule-sop-for-addressing-equipment-malfunctions-during-encapsulation-v-2-0/ Tue, 01 Apr 2025 14:16:00 +0000 https://www.pharmasop.in/?p=9482 Read More “Capsule: SOP for Addressing Equipment Malfunctions During Encapsulation – V 2.0” »

]]> Capsule: SOP for Addressing Equipment Malfunctions During Encapsulation – V 2.0

Standard Operating Procedure for Addressing Equipment Malfunctions During Encapsulation

Department Capsule Manufacturing
SOP No. SOP/CM/108/2025
Supersedes SOP/CM/108/2022
Page No. Page 1 of 6
Issue Date 01/02/2025
Effective Date 05/02/2025
Review Date 01/02/2026

1. Purpose

The purpose of this SOP is to establish the procedure for addressing equipment malfunctions during the encapsulation process. Identifying and rectifying malfunctions promptly is essential to maintaining production efficiency, product quality, and compliance with Good Manufacturing Practices (GMP).

2. Scope

This SOP applies to all capsule manufacturing equipment, including capsule filling machines, encapsulation systems, and related equipment. It covers the procedures for identifying, troubleshooting, and rectifying malfunctions during the encapsulation process.

3. Responsibilities

  • Production Operators: Responsible for identifying malfunctions during encapsulation, reporting issues promptly, and following the corrective actions outlined in this SOP.
  • Maintenance Team: Responsible for performing repairs or adjustments to malfunctioning equipment and ensuring that it meets operational specifications before resuming production.
  • Quality Control (QC) Team: Responsible for verifying that the encapsulation process resumes after repairs and meets product quality specifications.
  • Production Supervisor: Responsible for overseeing the equipment troubleshooting and repair process, ensuring that all procedures are followed, and coordinating between production, maintenance, and QC teams.

4. Accountability

The Capsule Manufacturing Supervisor is accountable for ensuring that all equipment malfunctions are addressed promptly, and production is not delayed. The Maintenance Manager is accountable for ensuring that equipment repairs are performed effectively, while the QA Manager is responsible for ensuring that product quality standards are met post-repair.

5. Procedure

5.1 Identifying Equipment Malfunctions

The first step in addressing equipment malfunctions is to identify issues as early as possible:

  1. Monitor Equipment Performance

    1. Regularly monitor the performance of capsule filling machines and other related equipment during production. Check for abnormalities such as irregular fill volumes, capsule leakage, or incomplete sealing.
    2. Ensure that operators are trained to recognize equipment malfunctions, such as strange noises, abnormal vibration, or error messages on the control panels.
  2. Report Malfunctions

    1. If an issue is detected, the production operator should immediately report the malfunction to the Production Supervisor and the Maintenance Team.
    2. Record the issue in the Equipment Malfunction Log (Annexure-1) with details of the malfunction, time of occurrence, and any relevant observations.

5.2 Troubleshooting Equipment Issues

Once a malfunction is reported, follow the troubleshooting process to identify the root cause:

  1. Consult Equipment Manuals

    1. Refer to the equipment manuals and troubleshooting guides for specific machines involved in the malfunction. Follow the manufacturer’s recommendations for addressing the issue.
  2. Perform Diagnostics

    1. The Maintenance Team should run diagnostic tests, if available, to detect any electrical or mechanical issues with the equipment.
    2. If the malfunction involves a mechanical failure, check for issues such as blockages, wear and tear, or component misalignment.
  3. Identify and Correct the Problem

    1. After diagnosing the malfunction, perform the necessary repairs or adjustments. Common fixes may involve recalibration, replacing faulty components, or cleaning the equipment to remove blockages.
    2. Ensure that any damaged components are replaced with certified spare parts to maintain equipment performance and ensure GMP compliance.

5.3 Testing and Verifying Equipment after Repairs

Once repairs are made, conduct tests to ensure that the equipment is functioning properly:

  1. Test the Equipment

    1. After making repairs, conduct a series of tests to verify that the machine is operating correctly. This may involve running a few test batches to check capsule fill volumes, sealing, and weight consistency.
    2. Ensure that all functions of the equipment are restored to their original specifications, such as filling speed, capsule alignment, and sealing integrity.
  2. Document Test Results

    1. Record the test results in the Equipment Verification Log (Annexure-2) to confirm that the equipment has passed all tests and is ready to resume production.
    2. Ensure that the test results are reviewed and approved by the Production Supervisor and the QA team.

5.4 Resuming Production

Once the malfunction is resolved and the equipment is verified to be functioning properly, proceed with resuming production:

  1. Resume Production

    1. Once the equipment passes all tests, production can resume. Ensure that production operators are informed that the issue has been resolved and that they are ready to continue the process.
  2. Monitor the Equipment

    1. Monitor the equipment closely during the initial production runs after the malfunction is addressed. Pay attention to any signs that the problem might recur.

5.5 Documentation and Reporting

Proper documentation of the malfunction, corrective actions, and testing is essential for traceability and regulatory compliance:

  1. Document the Malfunction

    1. Complete the Equipment Malfunction Log (Annexure-1) with all relevant details about the malfunction, the root cause, and the actions taken to correct the issue.
  2. Complete the Equipment Verification Log

    1. After completing the repairs and tests, ensure that the Equipment Verification Log (Annexure-2) is updated to reflect that the equipment is back to its operational state.

6. Abbreviations

  • SOP: Standard Operating Procedure
  • GMP: Good Manufacturing Practice
  • QC: Quality Control
  • QA: Quality Assurance
  • PM: Preventive Maintenance
  • RM: Raw Material

7. Documents

  1. Equipment Malfunction Log (Annexure-1)
  2. Equipment Verification Log (Annexure-2)
  3. Deviation Log (Annexure-3)
  4. Maintenance Log (Annexure-4)

8. References

  • USP <1163> – Pharmaceutical Dosage Forms: Capsules
  • FDA Guidelines for Capsule Manufacturing
  • Good Manufacturing Practice (GMP) Guidelines

9. SOP Version

Version: 2
You said:
​continue
ChatGPT said:
Certainly! Continuing from SOP 108: SOP for Addressing Equipment Malfunctions During Encapsulation, here is the remainder:

html
Copy

9. SOP Version

Version: 2.0

10. Approval Section

Prepared By Checked By Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Equipment Malfunction Log

Malfunction ID Batch ID Description Root Cause Corrective Action Operator Approval Status
MF-001 Batch 001 Capsule filling machine stopped unexpectedly Electrical short-circuit in motor Replaced motor and reset machine settings John Doe Approved

Annexure-2: Equipment Verification Log

Test ID Test Description Test Result Operator Verification Date
TEST-001 Filling accuracy test Pass Jane Smith 02/02/2025

Annexure-3: Deviation Log

Deviation ID Batch ID Description Corrective Action Operator Approval Status
DEV-001 Batch 001 Irregular capsule weight Recalibrated the capsule filling machine John Doe Approved

Annexure-4: Maintenance Log

Equipment ID Maintenance Date Maintenance Activity Performed By Next Maintenance Due
Filling Machine 001 02/02/2025 Replaced motor and calibrated sensors Jane Smith 02/02/2026

Revision History:

Revision Date Revision No. Revision Details Reason for Revision Approved By
01/01/2024 1.0 Initial Version New SOP Creation QA Head
01/02/2025 2.0 Updated troubleshooting and corrective action procedures Clarified equipment malfunction handling QA Head
]]> Capsule: SOP for Monitoring Capsule-Fill Density in Production – V 2.0 https://www.pharmasop.in/capsule-sop-for-monitoring-capsule-fill-density-in-production-v-2-0/ Tue, 01 Apr 2025 07:26:00 +0000 https://www.pharmasop.in/?p=9481 Read More “Capsule: SOP for Monitoring Capsule-Fill Density in Production – V 2.0” »

]]> Capsule: SOP for Monitoring Capsule-Fill Density in Production – V 2.0

Standard Operating Procedure for Monitoring Capsule-Fill Density in Production

Department Capsule Manufacturing
SOP No. SOP/CM/107/2025
Supersedes SOP/CM/107/2022
Page No. Page 1 of 6
Issue Date 01/02/2025
Effective Date 05/02/2025
Review Date 01/02/2026

1. Purpose

The purpose of this SOP is to establish the procedure for monitoring the fill density of capsules during the manufacturing process. Ensuring proper fill density is critical for maintaining product consistency, ensuring accurate dosing, and meeting regulatory standards.

2. Scope

This SOP applies to all processes involved in capsule filling, including the preparation of the fill material, monitoring during encapsulation, and verification of fill density for both hard gelatin and soft gelatin capsules.

3. Responsibilities

  • Production Operators: Responsible for performing the fill density checks as outlined in this SOP and ensuring the correct fill density is maintained during capsule production.
  • Quality Control (QC) Team: Responsible for conducting routine checks of capsule fill density, recording data, and performing corrective actions in case of deviations.
  • Quality Assurance (QA) Team: Ensures compliance with the SOP and regulatory requirements. Reviews documentation and test results to verify fill density compliance.
  • Production Supervisor: Oversees the capsule filling process, ensures that operators follow the SOP, and ensures that any issues are addressed promptly.

4. Accountability

The Capsule Manufacturing Supervisor is accountable for ensuring that fill density is monitored as per the SOP, and corrective actions are taken if necessary. The QA Manager is responsible for overseeing the overall compliance and ensuring the final product meets the required specifications.

5. Procedure

5.1 Monitoring Capsule-Fill Density

Monitor the fill density during capsule production to ensure that each capsule meets the specified requirements for content uniformity:

  1. Prepare for Density Monitoring

    1. Ensure that the capsule filling machine is calibrated and functioning properly before starting production.
    2. Verify that the fill material is adequately mixed and that the granules or powder are uniform in size and consistency.
  2. Select Sampling Method

    1. Randomly select a set number of capsules at different stages of the production run (e.g., every 30 minutes or after every 500 capsules). The selected samples should be representative of the entire batch.
    2. Document the time of sampling and batch number in the Sampling Log (Annexure-1).
  3. Measure Capsule-Fill Density

    1. Weigh each capsule individually and record the data. Ensure the use of an analytical balance calibrated according to the prescribed standards.
    2. Calculate the fill density by dividing the weight of the capsule by the known volume of the capsule shell. Compare the result to the specification limits for the fill density.
    3. If using liquid-filled capsules, ensure that the liquid is evenly distributed and that there are no air bubbles present in the capsule before weighing.
  4. Document Results

    1. Record the fill density for each capsule sampled, including the time, weight, and calculated density, in the Fill Density Log (Annexure-2).
    2. Ensure that all data entries are signed off by the responsible operator and reviewed by QC personnel.

5.2 Handling Deviations

If the capsule fill density does not meet the specified range, take the following corrective actions:

  1. Investigate the Cause of Deviation

    1. Identify any factors that could have contributed to the deviation, such as equipment malfunction, variation in raw materials, or incorrect fill material preparation.
    2. Check the capsule filling machine for proper calibration, and ensure that there is no material build-up in the feeding system.
  2. Correct the Process

    1. Adjust the machine settings, refill material preparation, or capsule handling as needed to correct the fill density deviation.
    2. If the issue cannot be resolved immediately, halt the production process and investigate further.
  3. Re-sample and Re-test

    1. After adjustments are made, conduct a new set of random tests to ensure that the fill density is back within acceptable limits.
    2. Document all findings, including the cause of deviation and the actions taken, in the Deviation Log (Annexure-3).

5.3 Frequency of Monitoring

The frequency of monitoring depends on the production volume and batch size. It is recommended to monitor fill density at regular intervals:

  1. For small batches, conduct fill density monitoring at least once every 100 capsules.
  2. For large batches, conduct monitoring at least once every 500 capsules or every 30 minutes of production.
  3. Increase the frequency of checks if any inconsistencies are detected or if adjustments are made to the filling process.

5.4 Final Approval and Release

Once the monitoring process is completed and the fill density is verified to meet specifications, proceed with the following steps:

  1. QA Review

    1. The QA team reviews all fill density records, including any deviations and corrective actions taken.
    2. Ensure that all data is complete and accurate, and that the batch complies with the fill density specifications.
  2. Approval for Release

    1. If the capsule fill density is within the required range, approve the batch for continued production or packaging.

6. Abbreviations

  • SOP: Standard Operating Procedure
  • GMP: Good Manufacturing Practice
  • QC: Quality Control
  • QA: Quality Assurance

7. Documents

  1. Fill Density Log (Annexure-2)
  2. Sampling Log (Annexure-1)
  3. Deviation Log (Annexure-3)
  4. Batch Records (Annexure-4)

8. References

  • USP <1163> – Pharmaceutical Dosage Forms: Capsules
  • FDA Guidelines for Capsule Manufacturing
  • Good Manufacturing Practice (GMP) Guidelines

9. SOP Version

Version: 2.0

10. Approval Section

Prepared By Checked By Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Sampling Log

Sample ID Sampling Time Operator Batch ID
Sample 001 10:00 AM John Doe Batch 001

Annexure-2: Fill Density Log

Sample ID Weight (mg) Fill Density (g/cm³) Pass/Fail Operator
Sample 001 500 0.75 Pass Jane Smith

Annexure-3: Deviation Log

Deviation ID Batch ID Description Corrective Action
You said:
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Corrective Action Operator Approval Status
DEV-001 Batch 001 Fill density outside acceptable range Re-calibrated machine and adjusted material flow John Doe Approved

Annexure-4: Batch Records

Batch ID Gelatin Composition Fill Material Operator Adjustments Made Approval Status
Batch 001 Standard Powdered Fill Jane Smith Adjusted for temperature variation in production environment Approved

Revision History:

Revision Date Revision No. Revision Details Reason for Revision Approved By
01/01/2024 1.0 Initial version New SOP Creation QA Head
01/02/2025 2.0 Updated monitoring frequency and adjustments Improved accuracy and compliance QA Head
]]> Capsule: SOP for Adjusting Gelatin Composition for Seasonal Variations – V 2.0 https://www.pharmasop.in/capsule-sop-for-adjusting-gelatin-composition-for-seasonal-variations-v-2-0-2/ Tue, 01 Apr 2025 00:36:00 +0000 https://www.pharmasop.in/?p=9480 Read More “Capsule: SOP for Adjusting Gelatin Composition for Seasonal Variations – V 2.0” »

]]> Capsule: SOP for Adjusting Gelatin Composition for Seasonal Variations – V 2.0

Standard Operating Procedure for Adjusting Gelatin Composition for Seasonal Variations

Department Capsule Manufacturing
SOP No. SOP/CM/106/2025
Supersedes SOP/CM/106/2022
Page No. Page 1 of 6
Issue Date 01/02/2025
Effective Date 05/02/2025
Review Date 01/02/2026

1. Purpose

The purpose of this SOP is to outline the procedure for adjusting gelatin composition in capsule manufacturing to account for seasonal variations in environmental conditions. Changes in temperature, humidity, and other factors during different seasons can affect the properties of gelatin, necessitating adjustments to maintain product quality.

2. Scope

This SOP applies to all gelatin-based capsule manufacturing processes where the composition may need to be adjusted based on seasonal variations. It includes adjustments to gelatin concentration, additives, and processing conditions.

3. Responsibilities

  • Production Operators: Responsible for implementing the adjustments to the gelatin composition according to the SOP and ensuring consistent quality during production.
  • Quality Control (QC) Team: Responsible for monitoring the properties of the gelatin and conducting tests to verify the suitability of the adjusted composition.
  • Quality Assurance (QA) Team: Ensures that all adjustments are documented and that the production process complies with regulatory standards. Reviews and approves the adjusted gelatin composition.
  • Production Supervisor: Oversees the entire process, ensures that adjustments are made correctly, and coordinates between production, QC, and QA teams.

4. Accountability

The Capsule Manufacturing Supervisor is accountable for ensuring that adjustments to the gelatin composition are made in compliance with this SOP. The QA Manager is responsible for verifying the adjustments and reviewing the final product for compliance with quality standards.

5. Procedure

5.1 Identifying Seasonal Variations

To determine the need for adjusting gelatin composition, monitor the environmental conditions and identify any seasonal variations that may affect the manufacturing process:

  1. Monitor Temperature and Humidity

    1. Track temperature and humidity levels in the production area to identify seasonal fluctuations. Ensure that the production environment is within the ideal range for gelatin processing.
    2. Document these environmental conditions regularly in the Environmental Monitoring Log (Annexure-1).
  2. Evaluate Gelatin Properties

    1. Regularly assess the properties of the gelatin, including its viscosity, moisture content, and solubility, to determine if seasonal variations are affecting the material.
    2. Record observations in the Gelatin Properties Log (Annexure-2) to track trends over time.

5.2 Adjusting Gelatin Composition

Once seasonal variations have been identified, adjust the gelatin composition accordingly to maintain product quality:

  1. Adjust Gelatin Concentration

    1. Increase or decrease the gelatin concentration as needed based on temperature and humidity. Higher humidity may require reducing the gelatin concentration to maintain consistency, while lower humidity may require an increase.
    2. Consult with the R&D or formulation team to determine the ideal concentration for the current environmental conditions.
  2. Modify Additives

    1. Adjust the quantity of plasticizers, stabilizers, or other additives to compensate for changes in gelatin properties caused by seasonal changes.
    2. Ensure that the adjusted additives do not affect the final capsule’s quality or stability.
  3. Monitor Gelatin Melting Point

    1. Check the melting point of the gelatin regularly during seasonal transitions, as changes in temperature may affect the gelatin’s behavior during encapsulation.
    2. Adjust the encapsulation temperature if necessary to ensure proper sealing of the capsules.

5.3 Conducting Quality Control Tests

After adjusting the gelatin composition, conduct the necessary quality control tests to verify that the adjustments have not negatively impacted the quality of the capsules:

  1. Gelatin Testing

    1. Perform tests on the gelatin to ensure that it meets the required viscosity, solubility, and gel strength. This ensures that the gelatin will perform properly during capsule filling and sealing.
    2. Document test results in the Gelatin Quality Control Log (Annexure-3).
  2. Capsule Testing

    1. Conduct tests on filled capsules to ensure that they meet the necessary specifications for weight, size, fill volume, and sealing integrity.
    2. If the capsules do not meet specifications, revisit the adjustments to the gelatin composition and make further refinements.

5.4 Monitoring Production

Monitor the production process to ensure that the adjusted gelatin composition is functioning as intended:

  1. Observe Gelatin Flow

    1. Monitor the flow of the gelatin during capsule filling to ensure smooth processing without clogging or irregular filling.
    2. Document any irregularities in the Gelatin Flow Log (Annexure-4) and adjust the composition as needed to maintain optimal flow.
  2. Monitor Capsule Sealing

    1. Check the capsule sealing process to ensure that the adjusted gelatin composition provides a strong and consistent seal. This is especially important during colder weather when gelatin may become more brittle.

5.5 Final Approval and Release

Once the gelatin composition adjustments have been made and the production process is running smoothly, proceed with the following steps:

  1. QA Review

    1. The QA team should review all records, including quality control tests, batch records, and adjustments made to the gelatin composition, to ensure compliance with the required standards.
  2. Approval for Production

    1. If the adjusted gelatin composition is verified to meet the required specifications, approve the batch for continued production and packaging.

6. Abbreviations

  • SOP: Standard Operating Procedure
  • GMP: Good Manufacturing Practice
  • QC: Quality Control
  • QA: Quality Assurance

7. Documents

  1. Gelatin Properties Log (Annexure-2)
  2. Gelatin Quality Control Log (Annexure-3)
  3. Gelatin Flow Log (Annexure-4)
  4. Batch Records (Annexure-5)

8. References

  • USP <1163> – Pharmaceutical Dosage Forms: Capsules
  • FDA Guidelines for Capsule Manufacturing
  • Good Manufacturing Practice (GMP) Guidelines

9. SOP Version

Version: 2.0

10. Approval Section

Prepared By Checked By Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Environmental Monitoring Log

Date Temperature (°C) Humidity (%) Operator
01/02/2025 22°C 55% John Doe

Annexure-2: Gelatin Properties Log

Date Viscosity (cP) Moisture Content (%) Solubility (%) Operator
01/02/2025 300 13% 98% Jane Smith

Revision History:

Revision Date Revision No. Revision Details Reason for Revision Approved By
01/01/2024 1.0 Initial Version New SOP Creation QA Head
01/02/2025 2.0 Updated gelatin adjustment procedures Seasonal Variation Adaptation QA Head
]]> Capsule: SOP for Adjusting Gelatin Composition for Seasonal Variations – V 2.0 https://www.pharmasop.in/capsule-sop-for-adjusting-gelatin-composition-for-seasonal-variations-v-2-0/ Mon, 31 Mar 2025 17:46:00 +0000 https://www.pharmasop.in/?p=9479 Read More “Capsule: SOP for Adjusting Gelatin Composition for Seasonal Variations – V 2.0” »

]]> Capsule: SOP for Adjusting Gelatin Composition for Seasonal Variations – V 2.0

Standard Operating Procedure for Adjusting Gelatin Composition for Seasonal Variations

Department Capsule Manufacturing
SOP No. SOP/CM/106/2025
Supersedes SOP/CM/106/2022
Page No. Page 1 of 6
Issue Date 01/02/2025
Effective Date 05/02/2025
Review Date 01/02/2026

1. Purpose

The purpose of this SOP is to outline the procedure for adjusting gelatin composition in capsule manufacturing to account for seasonal variations in environmental conditions. Changes in temperature, humidity, and other factors during different seasons can affect the properties of gelatin, necessitating adjustments to maintain product quality.

2. Scope

This SOP applies to all gelatin-based capsule manufacturing processes where the composition may need to be adjusted based on seasonal variations. It includes adjustments to gelatin concentration, additives, and processing conditions.

3. Responsibilities

  • Production Operators: Responsible for implementing the adjustments to the gelatin composition according to the SOP and ensuring consistent quality during production.
  • Quality Control (QC) Team: Responsible for monitoring the properties of the gelatin and conducting tests to verify the suitability of the adjusted composition.
  • Quality Assurance (QA) Team: Ensures that all adjustments are documented and that the production process complies with regulatory standards. Reviews and approves the adjusted gelatin composition.
  • Production Supervisor: Oversees the entire process, ensures that adjustments are made correctly, and coordinates between production, QC, and QA teams.

4. Accountability

The Capsule Manufacturing Supervisor is accountable for ensuring that adjustments to the gelatin composition are made in compliance with this SOP. The QA Manager is responsible for verifying the adjustments and reviewing the final product for compliance with quality standards.

5. Procedure

5.1 Identifying Seasonal Variations

To determine the need for adjusting gelatin composition, monitor the environmental conditions and identify any seasonal variations that may affect the manufacturing process:

  1. Monitor Temperature and Humidity

    1. Track temperature and humidity levels in the production area to identify seasonal fluctuations. Ensure that the production environment is within the ideal range for gelatin processing.
    2. Document these environmental conditions regularly in the Environmental Monitoring Log (Annexure-1).
  2. Evaluate Gelatin Properties

    1. Regularly assess the properties of the gelatin, including its viscosity, moisture content, and solubility, to determine if seasonal variations are affecting the material.
    2. Record observations in the Gelatin Properties Log (Annexure-2) to track trends over time.

5.2 Adjusting Gelatin Composition

Once seasonal variations have been identified, adjust the gelatin composition accordingly to maintain product quality:

  1. Adjust Gelatin Concentration

    1. Increase or decrease the gelatin concentration as needed based on temperature and humidity. Higher humidity may require reducing the gelatin concentration to maintain consistency, while lower humidity may require an increase.
    2. Consult with the R&D or formulation team to determine the ideal concentration for the current environmental conditions.
  2. Modify Additives

    1. Adjust the quantity of plasticizers, stabilizers, or other additives to compensate for changes in gelatin properties caused by seasonal changes.
    2. Ensure that the adjusted additives do not affect the final capsule’s quality or stability.
  3. Monitor Gelatin Melting Point

    1. Check the melting point of the gelatin regularly during seasonal transitions, as changes in temperature may affect the gelatin’s behavior during encapsulation.
    2. Adjust the encapsulation temperature if necessary to ensure proper sealing of the capsules.

5.3 Conducting Quality Control Tests

After adjusting the gelatin composition, conduct the necessary quality control tests to verify that the adjustments have not negatively impacted the quality of the capsules:

  1. Gelatin Testing

    1. Perform tests on the gelatin to ensure that it meets the required viscosity, solubility, and gel strength. This ensures that the gelatin will perform properly during capsule filling and sealing.
    2. Document test results in the Gelatin Quality Control Log (Annexure-3).
  2. Capsule Testing

    1. Conduct tests on filled capsules to ensure that they meet the necessary specifications for weight, size, fill volume, and sealing integrity.
    2. If the capsules do not meet specifications, revisit the adjustments to the gelatin composition and make further refinements.

5.4 Monitoring Production

Monitor the production process to ensure that the adjusted gelatin composition is functioning as intended:

  1. Observe Gelatin Flow

    1. Monitor the flow of the gelatin during capsule filling to ensure smooth processing without clogging or irregular filling.
    2. Document any irregularities in the Gelatin Flow Log (Annexure-4) and adjust the composition as needed to maintain optimal flow.
  2. Monitor Capsule Sealing

    1. Check the capsule sealing process to ensure that the adjusted gelatin composition provides a strong and consistent seal. This is especially important during colder weather when gelatin may become more brittle.

5.5 Final Approval and Release

Once the gelatin composition adjustments have been made and the production process is running smoothly, proceed with the following steps:

  1. QA Review

    1. The QA team should review all records, including quality control tests, batch records, and adjustments made to the gelatin composition, to ensure compliance with the required standards.
  2. Approval for Production

    1. If the adjusted gelatin composition is verified to meet the required specifications, approve the batch for continued production and packaging.

6. Abbreviations

  • SOP: Standard Operating Procedure
  • GMP: Good Manufacturing Practice
  • QC: Quality Control
  • QA: Quality Assurance

7. Documents

  1. Gelatin Properties Log (Annexure-2)
  2. Gelatin Quality Control Log (Annexure-3)
  3. Gelatin Flow Log (Annexure-4)
  4. Batch Records (Annexure-5)

8. References

  • USP <1163> – Pharmaceutical Dosage Forms: Capsules
  • FDA Guidelines for Capsule Manufacturing
  • Good Manufacturing Practice (GMP) Guidelines

9. SOP Version

Version: 2.0

10. Approval Section

Prepared By Checked By Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Environmental Monitoring Log

Date Temperature (°C) Humidity (%) Operator
01/02/2025 22°C 55% John Doe

Annexure-2: Gelatin Properties Log

Date Viscosity (cP) Moisture Content (%) Solubility (%) Operator
01/02/2025 300 13% 98% Jane Smith

Revision History:

Revision Date Revision No. Revision Details Reason for Revision Approved By
01/01/2024 1.0 Initial Version New SOP Creation QA Head
01/02/2025 2.0 Updated gelatin adjustment procedures Seasonal Variation Adaptation QA Head
]]> Capsule: SOP for Ensuring Compliance with GMP in Capsule Production – V 2.0 https://www.pharmasop.in/capsule-sop-for-ensuring-compliance-with-gmp-in-capsule-production-v-2-0/ Mon, 31 Mar 2025 10:56:00 +0000 https://www.pharmasop.in/?p=9478 Read More “Capsule: SOP for Ensuring Compliance with GMP in Capsule Production – V 2.0” »

]]> Capsule: SOP for Ensuring Compliance with GMP in Capsule Production – V 2.0

Standard Operating Procedure for Ensuring Compliance with GMP in Capsule Production

Department Capsule Manufacturing
SOP No. SOP/CM/105/2025
Supersedes SOP/CM/105/2022
Page No. Page 1 of 6
Issue Date 01/02/2025
Effective Date 05/02/2025
Review Date 01/02/2026

1. Purpose

The purpose of this SOP is to establish the procedure for ensuring compliance with Good Manufacturing Practices (GMP) during capsule production. This procedure is designed to maintain the highest quality standards and ensure that all aspects of capsule manufacturing meet regulatory requirements.

2. Scope

This SOP applies to all aspects of capsule production, including raw material handling, formulation, encapsulation, drying, quality control testing, and packaging. It outlines the responsibilities and procedures to ensure that capsule production processes comply with GMP guidelines at all stages.

3. Responsibilities

  • Production Operators: Responsible for following the procedures outlined in this SOP, ensuring that capsule production processes are in compliance with GMP standards.
  • Quality Control (QC) Team: Responsible for overseeing the testing and monitoring of production processes to ensure compliance with GMP. QC will also document and report any deviations from GMP.
  • Quality Assurance (QA) Team: Ensures that the entire production process adheres to GMP standards and reviews all documentation to confirm compliance with regulatory requirements.
  • Production Supervisor: Responsible for supervising the production process and ensuring that all operators follow GMP guidelines. The supervisor must also manage corrective actions in case of deviations from GMP.

4. Accountability

The Capsule Manufacturing Supervisor is accountable for ensuring compliance with GMP during the production process. The QA Manager is responsible for reviewing and approving all GMP compliance-related documentation and actions.

5. Procedure

5.1 GMP Training and Education

Ensure that all personnel involved in capsule production are properly trained and educated on GMP guidelines:

  1. Provide Initial GMP Training

    1. All new employees involved in capsule production must undergo an initial GMP training session before beginning work.
    2. The training should cover GMP regulations, quality control procedures, and the importance of maintaining compliance in capsule production.
  2. Conduct Regular Refresher Training

    1. Conduct periodic refresher training for all production staff to ensure that they stay updated with any changes in GMP regulations or internal processes.
    2. Keep records of all training sessions, including the names of attendees, training dates, and topics covered, in the Training Log (Annexure-1).

5.2 Document Control and Record Keeping

Ensure that all manufacturing records are accurate, complete, and maintained according to GMP guidelines:

  1. Maintain Accurate Batch Records

    1. Ensure that all batch records are completed accurately, including the recording of raw material batches, production processes, equipment used, and test results.
    2. Batch records should be signed off by authorized personnel and reviewed by QA for completeness and accuracy.
  2. Document Handling

    1. Ensure that all GMP-related documents (e.g., batch records, SOPs, test results) are properly stored and controlled to prevent unauthorized access or changes.
    2. Use a document control system to track the revision history and approval of all GMP-related documents.

5.3 Equipment Calibration and Maintenance

Ensure that all equipment used in capsule production is properly calibrated, maintained, and functioning:

  1. Regular Calibration of Equipment

    1. All equipment used in capsule manufacturing, such as filling machines, drying ovens, and QC testing equipment, must be calibrated according to the manufacturer’s specifications.
    2. Calibration records should be maintained in the Equipment Calibration Log (Annexure-2), including calibration dates, results, and any corrective actions taken.
  2. Preventive Maintenance

    1. Establish a preventive maintenance schedule for all equipment used in capsule production. This schedule should include routine inspections, cleaning, and part replacements to ensure optimal performance.
    2. Record all maintenance activities in the Maintenance Log (Annexure-3) to ensure traceability and compliance with GMP guidelines.

5.4 Production and Process Controls

Ensure that all production processes are controlled and monitored to maintain compliance with GMP:

  1. Monitor Critical Process Parameters

    1. Monitor critical parameters during capsule manufacturing, such as temperature, humidity, capsule weight, and fill volume, to ensure that they remain within acceptable limits.
    2. Use automated systems to continuously monitor these parameters, and record the data in the Production Monitoring Log (Annexure-4).
  2. Investigate Deviations

    1. If any process deviation is detected, immediately investigate the cause of the deviation, and implement corrective actions to return the process to compliance.
    2. Document all deviations and corrective actions in the Deviation Log (Annexure-5), and review them to prevent recurrence.

5.5 Compliance Audits and Inspections

Regularly conduct audits and inspections to verify compliance with GMP and regulatory requirements:

  1. Conduct Internal Audits

    1. Conduct regular internal GMP audits to assess compliance with SOPs, equipment calibration, documentation, and overall manufacturing processes.
    2. Audit findings should be documented, and corrective actions should be implemented as necessary.
  2. Prepare for External Audits

    1. Prepare for external GMP inspections by regulatory bodies (e.g., FDA, EMA) by ensuring that all documents, records, and procedures are up-to-date and in compliance with regulatory requirements.
    2. Address any observations made during external audits and implement corrective actions to maintain compliance.

5.6 Final Approval and Release

Once all GMP procedures have been followed and documented, the following steps should be taken:

  1. QA Review

    1. The QA team reviews all GMP-related records, including batch records, equipment maintenance logs, and deviation reports, to ensure that the production process complies with GMP standards.
  2. Approval for Release

    1. If the batch complies with GMP and all documentation is complete, the batch is approved for release and packaging.

6. Abbreviations

  • SOP: Standard Operating Procedure
  • GMP: Good Manufacturing Practice
  • QC: Quality Control
  • QA: Quality Assurance
  • BPR: Batch Production Record

7. Documents

  1. Training Log (Annexure-1)
  2. Equipment Calibration Log (Annexure-2)
  3. Maintenance Log (Annexure-3)
  4. Production Monitoring Log (Annexure-4)
  5. Deviation Log (Annexure-5)

8. References

  • USP <1163> – Pharmaceutical Dosage Forms: Capsules
  • FDA Guidelines for Capsule Manufacturing
  • Good Manufacturing Practice (GMP) Guidelines

9. SOP Version

Version: 2.0

10. Approval Section

Prepared By Checked By Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Training Log

Employee Name Training Date Training Topic Trainer Sign-off
John Doe 02/01/2025 GMP Training Jane Smith ✔

Annexure-2: Equipment Calibration Log

Equipment ID Calibration Date Calibration Result Next Calibration Date Operator
Filling Machine 001 01/02/2025 Pass 01/02/2026 John Doe

Annexure-3: Maintenance Log

Equipment ID Maintenance Date Maintenance Activity Performed By Next Maintenance Due
Sealing Machine 001 02/02/2025 Replaced sealing part Jane Smith 02/02/2026

Annexure-4: Production Monitoring Log

Batch ID Monitoring Date Parameter Monitored Result Action Taken
Batch 001 01/02/2025 Capsule Weight 500 mg None

Annexure-5: Deviation Log

Deviation ID Batch ID Deviation Description Corrective Action Taken Operator Approval Status
DEV-001 Batch 001 Capsule weight outside acceptable range Recalibrated machine John Doe Approved

Revision History:

Revision Date Revision No. Revision Details Reason for Revision Approved By
01/01/2024 1.0 Initial Version New SOP Creation QA Head
01/02/2025 2.0 Updated compliance monitoring procedures Standardization QA Head
]]> Capsule: SOP for Conducting Randomized Sampling of Capsules – V 2.0 https://www.pharmasop.in/capsule-sop-for-conducting-randomized-sampling-of-capsules-v-2-0/ Mon, 31 Mar 2025 04:06:00 +0000 https://www.pharmasop.in/?p=9477 Read More “Capsule: SOP for Conducting Randomized Sampling of Capsules – V 2.0” »

]]> Capsule: SOP for Conducting Randomized Sampling of Capsules – V 2.0

Standard Operating Procedure for Conducting Randomized Sampling of Capsules

Department Capsule Manufacturing
SOP No. SOP/CM/104/2025
Supersedes SOP/CM/104/2022
Page No. Page 1 of 6
Issue Date 01/02/2025
Effective Date 05/02/2025
Review Date 01/02/2026

1. Purpose

The purpose of this SOP is to establish a standardized procedure for conducting randomized sampling of capsules. Randomized sampling ensures that the samples collected are representative of the entire batch, allowing for accurate quality control testing and ensuring the final product meets all quality specifications.

2. Scope

This SOP applies to the process of random sampling during the capsule manufacturing process. It covers the selection, collection, and handling of samples from the production batch for quality control testing.

3. Responsibilities

  • Production Operators: Responsible for following the sampling procedure to collect samples from the production batch and ensuring proper labeling.
  • Quality Control (QC) Team: Responsible for overseeing the randomized sampling process, ensuring the proper collection of samples, and conducting the necessary tests on the samples.
  • Quality Assurance (QA) Team: Ensures that the sampling process is conducted according to the SOP and reviews the testing results to ensure that the batch meets quality specifications.
  • Production Supervisor: Oversees the entire sampling process, ensures that proper sampling procedures are followed, and resolves any issues that arise during the sampling process.

4. Accountability

The Capsule Manufacturing Supervisor is accountable for ensuring that the randomized sampling is conducted according to this SOP. The QA Manager is responsible for reviewing and approving the sampling process and ensuring that the results are in compliance with quality standards.

5. Procedure

5.1 Sample Size Determination

Before collecting samples, determine the sample size based on the following:

  1. Determine Sample Size

    1. Calculate the appropriate sample size based on batch size, the expected variability of the product, and the level of confidence required for the testing.
    2. Consult standard sampling tables or quality control guidelines to determine the minimum number of samples required for the batch size.
  2. Confirm Sampling Requirements

    1. Ensure that the sample size is representative of the entire batch and that all critical quality attributes (e.g., size, weight, fill volume, appearance) will be covered in the sampling process.
    2. Ensure that the sampling plan adheres to industry standards or regulatory requirements for randomized sampling.

5.2 Randomized Sampling Process

Follow these steps to ensure that sampling is conducted randomly and represents the entire production batch:

  1. Ensure Random Selection

    1. Choose capsules randomly from different stages of the manufacturing process, ensuring that the selected capsules are representative of the entire batch.
    2. Do not select samples based on visual appearance to avoid selection bias.
  2. Collect the Samples

    1. Use clean and properly labeled sampling containers to collect the samples. Ensure that the capsules are not contaminated during the sampling process.
    2. Collect the samples from different locations in the batch, ensuring that they represent the entire manufacturing run.
  3. Record Sample Information

    1. Label each sample with the batch number, sampling time, and location. Ensure that the samples are stored in a clean, secure area until testing.
    2. Document all relevant details in the Sample Collection Log (Annexure-1), including the operator’s name, the time of sampling, and any other relevant observations.

5.3 Quality Control Testing

Once the samples have been collected, the following steps must be followed to test the capsules for compliance:

  1. Test the Samples

    1. QC will perform the necessary tests on the samples to evaluate the critical quality attributes, such as size, weight, fill volume, and appearance.
    2. Tests should be performed according to the predefined specifications for the capsules, ensuring that they meet the required standards.
  2. Analyze Test Results

    1. Analyze the test results to determine whether the capsules meet the established quality standards.
    2. If the results are within acceptable limits, the batch is deemed to pass the randomized sampling test and can proceed to the next stage of production.
    3. If the results are outside the acceptable limits, identify the cause of the deviation and take corrective actions.
  3. Document the Results

    1. Document all test results, including any deviations found, in the Sampling and Testing Report (Annexure-2).
    2. Ensure that all documentation is reviewed and signed by the responsible QC team member.

5.4 Handling Deviations and Corrective Actions

If the sampled capsules do not meet the quality specifications, follow these steps:

  1. Identify the Cause of Deviation

    1. Investigate the root cause of the deviation by reviewing the manufacturing process, materials, and equipment used during production.
    2. Consult with the production team to determine if any environmental factors, machine settings, or raw material issues contributed to the deviation.
  2. Implement Corrective Actions

    1. Take corrective actions, such as adjusting equipment settings, modifying the process, or addressing raw material issues, to prevent recurrence of the deviation.
    2. Retest the batch or affected samples after corrective actions are implemented to confirm that the issue has been resolved.
  3. Document the Deviation and Corrective Actions

    1. Record all deviations and corrective actions in the Deviation Log (Annexure-3) for future reference and regulatory compliance.

5.5 Final Approval and Release

Once the randomized sampling has been completed and any necessary corrective actions have been taken, the following steps must be taken:

  1. QA Review

    1. The QA team reviews the sampling results and corrective actions taken, ensuring that the batch meets the required quality specifications.
  2. Approval for Next Stage

    1. If the batch passes the randomized sampling and testing, the batch is approved for the next stage of production or packaging.

6. Abbreviations

  • SOP: Standard Operating Procedure
  • GMP: Good Manufacturing Practice
  • QC: Quality Control
  • QA: Quality Assurance
  • BPR: Batch Production Record

7. Documents

  1. Sample Collection Log (Annexure-1)
  2. Sampling and Testing Report (Annexure-2)
  3. Deviation Log (Annexure-3)

8. References

  • USP <1163> – Pharmaceutical Dosage Forms: Capsules
  • FDA Guidelines for Capsule Manufacturing
  • Good Manufacturing Practice (GMP) Guidelines

9. SOP Version

Version: 2.0

10. Approval Section

Prepared By Checked By Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Sample Collection Log

Sample ID Sample Location Sample Time Collected By Batch ID
Sample 001 Line 1 10:00 AM John Doe Batch 001
Sample 002 Line 2 10:15 AM Jane Smith Batch 001

Annexure-2: Sampling and Testing Report

Sample ID Test Parameter Test Result Deviations Corrective Action
Sample 001 Capsule Weight 500 mg No None
Sample 002 Fill Volume Standard No None

Annexure-3: Deviation Log

Deviation ID Batch ID Description Corrective Action Operator Approval Status
DEV-001 Batch 001 Capsule weight outside acceptable range Recalibrated machine John Doe Approved

Revision History:

Revision Date Revision No. Revision Details Reason for Revision Approved By
01/01/2024 1.0 Initial Version New SOP Creation QA Head
01/02/2025 2.0 Updated sampling procedures and documentation Standardization QA Head
]]> Capsule: SOP for Visual Inspection of Capsule Sealing – V 2.0 https://www.pharmasop.in/capsule-sop-for-visual-inspection-of-capsule-sealing-v-2-0/ Sun, 30 Mar 2025 21:16:00 +0000 https://www.pharmasop.in/?p=9476 Read More “Capsule: SOP for Visual Inspection of Capsule Sealing – V 2.0” »

]]> Capsule: SOP for Visual Inspection of Capsule Sealing – V 2.0

Standard Operating Procedure for Visual Inspection of Capsule Sealing

Department Capsule Manufacturing
SOP No. SOP/CM/103/2025
Supersedes SOP/CM/103/2022
Page No. Page 1 of 6
Issue Date 01/02/2025
Effective Date 05/02/2025
Review Date 01/02/2026

1. Purpose

The purpose of this SOP is to establish the procedure for the visual inspection of capsule sealing to ensure that capsules are sealed correctly, without leaks or defects. Proper capsule sealing is essential for maintaining the quality, stability, and safety of the product.

2. Scope

This SOP applies to the visual inspection of capsules during the sealing process. It includes the inspection of capsules for sealing integrity, ensuring that no leaks or improper seals are present before further processing or packaging.

3. Responsibilities

  • Production Operators: Responsible for visually inspecting capsules for sealing integrity during and after the sealing process. Operators must identify defects such as incomplete seals, cracks, or leaks.
  • Quality Control (QC) Team: Responsible for overseeing the inspection process, performing random spot checks, and verifying that the capsules meet quality standards for sealing.
  • Quality Assurance (QA) Team: Ensures the SOP is followed, reviews inspection records, and approves batches that meet sealing specifications for release.
  • Production Supervisor: Oversees the visual inspection process, ensures operators are trained in identifying seal defects, and resolves issues that arise during inspections.

4. Accountability

The Capsule Manufacturing Supervisor is accountable for ensuring that visual inspections of capsules are conducted correctly. The QA Manager is responsible for reviewing the inspection results and ensuring that the batch meets the required sealing specifications before release.

5. Procedure

5.1 Visual Inspection Setup

Before performing the visual inspection, ensure the following steps are completed:

  1. Prepare Inspection Area

    1. Ensure the inspection area is well-lit and clean. Proper lighting is essential for detecting seal defects, including incomplete or damaged seals.
    2. Set up the inspection station with clean tools and ensure that inspectors have access to necessary documentation (e.g., batch production record, inspection checklist).
  2. Verify Equipment Functionality

    1. Ensure that the sealing machine is properly calibrated and functioning according to the manufacturer’s specifications. This includes checking temperature settings, pressure, and sealing time.
    2. Verify that the capsule inspection equipment is in good working order, particularly if automated visual inspection systems are used.

5.2 Conducting the Visual Inspection

Follow these steps for visual inspection of capsule sealing:

  1. Inspect Seals for Completeness

    1. Check that each capsule has a complete and intact seal with no gaps, cracks, or visible openings.
    2. Inspect capsules for any incomplete seals that may cause leakage, contamination, or product loss during packaging.
  2. Check for Leaks

    1. Check the capsules for leaks by applying pressure or using appropriate equipment (e.g., vacuum or pressure test equipment) to identify compromised seals.
    2. Use visual inspection for leaks by looking for any product leakage from the capsule after it has been sealed.
  3. Inspect for Cracks or Damage

    1. Look for any cracks, chips, or deformation of the capsule shell that could impact product quality or lead to contamination during storage or transport.
    2. Inspect both the body and cap of the capsule to ensure that they are intact and there is no damage that could affect their functionality.
  4. Check for Proper Alignment

    1. Ensure that the capsule body and cap are aligned correctly, with no offset or misalignment that could result in an incomplete or defective seal.

5.3 Documentation of Inspection Results

Record the results of the visual inspection as follows:

  1. Record Inspection Findings

    1. Document the number of capsules inspected, the number of defective capsules, and the type of defect found (e.g., incomplete seals, cracks, leaks) in the Capsule Sealing Inspection Log (Annexure-1).
    2. For automated inspection systems, ensure that the inspection data is logged and stored for review.
  2. Retest Defective Capsules

    1. If defects are found, re-inspect the defective capsules manually or by using other inspection equipment to verify the severity of the issue.
    2. Document any corrective actions taken to resolve the issues, such as recalibrating equipment or adjusting sealing parameters.

5.4 Handling Defective Capsules

If defective capsules are identified, handle them as follows:

  1. Segregate Defective Capsules

    1. Immediately separate defective capsules from the acceptable batch to prevent contamination during packaging.
    2. Label the containers with the rejected capsules clearly, indicating the reason for rejection (e.g., incomplete seal, cracked shell, leakage).
  2. Reject and Document

    1. Reject the defective capsules based on the severity of the defect, and document the rejection in the Reject Log (Annexure-2).
    2. Investigate the cause of the defect and take corrective actions to prevent recurrence, such as adjusting machine settings or changing raw materials.

5.5 Final Approval for Packaging

Once the visual inspection is complete and all defective capsules have been addressed, proceed as follows:

  1. QA Review

    1. The QA team should review the inspection results, including any corrective actions taken, to ensure that the sealing process meets quality standards.
  2. Approval for Packaging

    1. If the capsules meet the required sealing specifications, the batch is approved for packaging and labeling.

6. Abbreviations

  • SOP: Standard Operating Procedure
  • GMP: Good Manufacturing Practice
  • QC: Quality Control
  • QA: Quality Assurance
  • BPR: Batch Production Record

7. Documents

  1. Capsule Sealing Inspection Log (Annexure-1)
  2. Reject Log (Annexure-2)

8. References

  • USP <1163> – Pharmaceutical Dosage Forms: Capsules
  • FDA Guidelines for Capsule Manufacturing
  • Good Manufacturing Practice (GMP) Guidelines

9. SOP Version

Version: 2.0

10. Approval Section

Prepared By Checked By Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Capsule Sealing Inspection Log

Sample ID Capsule Seal Integrity Defects Found Operator
Sample 001 Pass None John Doe
Sample 002 You said:
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Fail Cracked capsule Jane Smith

Annexure-2: Reject Log

Batch ID Reason for Rejection Number of Rejected Capsules Corrective Action
Batch 001 Incomplete seal 20 Recalibrated sealing machine

Revision History:

Revision Date Revision No. Revision Details Reason for Revision Approved By
01/01/2024 1.0 Initial Version New SOP Creation QA Head
01/02/2025 2.0 Updated inspection criteria and corrective actions Standardization QA Head
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