Standard Operating Procedure for Cleaning Stainless Steel Surfaces in Capsule Areas

1. Purpose

The purpose of this SOP is to outline the procedure for cleaning stainless steel surfaces in capsule manufacturing areas. Regular cleaning of stainless steel surfaces ensures that they remain free of contaminants and residues, which is essential for maintaining product quality and compliance with GMP (Good Manufacturing Practices).

2. Scope

This SOP applies to all stainless steel surfaces in the capsule manufacturing area, including surfaces of machinery, tools, equipment, and other stainless steel components used in the production of capsules.

3. Responsibilities

• Production Operators: Responsible for cleaning the stainless steel surfaces as per the SOP and ensuring that all tools and equipment are properly cleaned and documented.
• Production Supervisor: Ensures that the cleaning procedures are followed correctly, verifies the effectiveness of the cleaning, and ensures that cleaning logs are accurately completed.
• Quality Assurance (QA) Team: Verifies that the cleaning procedure meets GMP standards, ensures that the surfaces are clean and ready for use, and reviews the cleaning logs for completeness and accuracy.
• Maintenance Team: Assists with any necessary maintenance or repairs to stainless steel surfaces during or after the cleaning process, ensuring they are in proper working condition.

4. Accountability

The Production Supervisor is accountable for ensuring the cleaning of stainless steel surfaces as per this SOP. The QA team is responsible for ensuring that the cleaning methods are validated and compliant with GMP standards.

5. Procedure

5.1 Preparing for Cleaning

Before cleaning stainless steel surfaces, the following steps must be completed:

1. Ensure the Equipment is Not in Use
   1. Confirm that the equipment and tools are not in use during the cleaning process. If necessary, disconnect equipment from the power source to ensure safety.
   2. Make sure the area is isolated from the rest of the production line to prevent contamination.
2. Gather Cleaning Supplies
   1. Ensure that all cleaning materials are ready, including approved cleaning agents, brushes, lint-free cloths, deionized water, and sanitizing agents.
   2. Check that all cleaning agents are GMP-approved and safe for use on stainless steel surfaces.

5.2 Cleaning Procedure

Follow these steps to clean stainless steel surfaces:

1. Initial Rinse
   1. Rinse the stainless steel surfaces with warm water to remove any loose particles or residue.
   2. Ensure that the rinse water is discarded properly and that no contaminants remain on the surface.
2. Apply Cleaning Solution
   1. Apply an appropriate cleaning solution to the stainless steel surfaces. Ensure that the solution is safe for use on stainless steel and does not cause corrosion.
   2. Use a brush or soft cloth to scrub the surface and remove any accumulated residue or product materials.
3. Rinse Thoroughly
   1. Rinse the surface thoroughly with deionized water to remove all cleaning agents and residues.
   2. Ensure that no cleaning agents are left on the surface as they may affect the quality of the next production batch.
4. Sanitize the Surface
   1. If necessary, apply a GMP-approved sanitizing solution to disinfect the stainless steel surfaces.
   2. Allow the sanitizing agent to remain for the recommended contact time before rinsing it off with deionized water.
5. Dry the Surface
   1. Dry the stainless steel surfaces with a lint-free cloth or allow them to air dry completely before reassembly.
   2. Ensure that no moisture remains on the surface, as this could cause rusting or microbial growth.

5.3 Reassembly and Final Inspection

After cleaning, the following steps must be taken:

1. Inspect the Surface
   1. Inspect the cleaned stainless steel surfaces to ensure that no residue or cleaning agents remain.
   2. Check for any visible damage or signs of corrosion. If any defects are found, report them to the Maintenance Team for further action.
2. Reassemble Equipment
   1. If any parts were disassembled for cleaning, reassemble them and ensure that all components are securely fastened.
   2. Verify that the equipment is properly aligned and functioning as intended before restarting production.
3. QA Inspection
   1. The QA team must inspect the cleaned stainless steel surfaces to verify that the cleaning has been carried out according to the SOP.
   2. Once the inspection is completed and the surfaces are approved, the equipment is ready for use in the next production cycle.

5.4 Documentation and Recordkeeping

Ensure that all cleaning activities are properly documented as follows:

1. Complete Cleaning Logs
   1. Document all cleaning activities, including the date, time, operator, equipment ID, cleaning methods, and inspection results (refer to Annexure 1).
2. Maintain Records for Audits
   1. Store cleaning records for the required retention period (typically 5 years or as required by local regulations) and ensure that they are available for internal or regulatory audits.

6. Abbreviations

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

7. Documents

1. Annexure 1: Stainless Steel Surface Cleaning Log

8. References

• Good Manufacturing Practice (GMP) Guidelines
• 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals
• ICH Q7 – Good Manufacturing Practice for Active Pharmaceutical Ingredients

9. SOP Version

Version: 2.0

10. Approval Section

11. Annexures

Annexure 1: Stainless Steel Surface Cleaning Log

12. Revision History

Standard Operating Procedure for Ensuring Traceability in Capsule Manufacturing Documentation

1. Purpose

The purpose of this SOP is to ensure proper traceability of capsule manufacturing documentation. Traceability ensures that all manufacturing steps, materials, equipment, and personnel actions are documented, allowing for the complete tracking of a batch from production to final distribution.

2. Scope

This SOP applies to all documentation related to capsule manufacturing, including raw material receipt, batch records, in-process testing, packaging, and final release. It ensures that all documentation is properly linked to its corresponding batch and remains traceable for audits and regulatory inspections.

3. Responsibilities

• Quality Assurance (QA) Team: Ensures that all manufacturing documentation is complete, accurate, and traceable. QA verifies that all records are correctly linked to the corresponding batch.
• Production Team: Responsible for maintaining accurate batch records, documenting each step of the manufacturing process, and ensuring traceability between production activities.
• Warehouse Team: Ensures that all raw materials are documented with batch numbers and are traceable throughout the manufacturing process.
• Records Management Team: Responsible for the organization, storage, and retrieval of all manufacturing records to ensure they are traceable and readily available for audits.

4. Accountability

The QA Manager is accountable for overseeing the traceability of manufacturing documentation and ensuring compliance with this SOP. The Production Manager is responsible for maintaining accurate and traceable records for each batch of capsules.

5. Procedure

5.1 Documentation of Raw Materials

To ensure traceability of raw materials, follow these steps:

1. Record Raw Material Details
   1. Upon receipt, record the batch number, supplier, quantity, and lot number of each raw material in the Raw Material Receipt Log (refer to Annexure 1).
   2. Link each raw material batch to the corresponding capsule production batch for full traceability.
2. Verify Material Identification
   1. Before use in production, verify that each material is properly identified, and the documentation is complete and traceable.
   2. Ensure that materials are stored in clearly labeled areas to avoid mix-ups and facilitate traceability.

5.2 Documentation of Batch Records

To ensure traceability in the manufacturing process, follow these steps:

1. Complete Batch Manufacturing Records (BMR)
   1. For each batch of capsules, complete the Batch Manufacturing Record (BMR), including all process steps, equipment used, and operator details (refer to Annexure 2).
   2. Document each process step in real time to ensure accurate traceability from start to finish.
2. Record In-Process Testing
   1. Document all in-process testing, such as weight variation, hardness, dissolution, and other critical quality attributes.
   2. Link in-process test results to the relevant BMR and ensure traceability of each test result back to the specific batch.

5.3 Packaging Documentation

To maintain traceability during packaging, follow these steps:

1. Document Packaging Steps
   1. Document all packaging activities, including the packaging materials used (e.g., blisters, bottles, desiccants), batch numbers, and operators involved.
   2. Ensure that all packaging activities are linked to the corresponding batch through Batch Packing Records (refer to Annexure 3).
2. Labeling and Cartoning
   1. Record the labeling details for each packaging run, including label numbers and batch numbers for traceability.
   2. Ensure that the packaging batch numbers are linked to the production batch in the records.

5.4 Final Product Release and Documentation

Once the batch is finished, follow these steps for final release and documentation:

1. Review and Approve BMR
   1. The QA team must review the completed BMR, ensuring that all necessary documentation is included and that the batch complies with regulatory standards.
   2. Upon approval, sign off on the BMR, marking the batch as ready for release.
2. Record Final Product Details
   1. Record final product details, including batch number, quantity, and packaging information, in the final product release log.
   2. Ensure that all documentation for the batch is securely stored and easily accessible for traceability purposes.

5.5 Archiving and Retrieval of Records

To ensure traceability, follow these steps for record storage:

1. Secure Record Storage
   1. Store all documentation related to capsule production, including BMRs, in-process test records, and packaging records, in a secure location.
   2. Ensure that records are stored in compliance with regulatory requirements and company policies.
2. Ensure Easy Retrieval
   1. Maintain an organized filing system, whether physical or electronic, that allows for the quick retrieval of records for audits or inspections.

6. Abbreviations

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

7. Documents

1. Annexure 1: Raw Material Receipt Log
2. Annexure 2: Batch Manufacturing Record Template
3. Annexure 3: Batch Packing Record Template

8. References

• Good Manufacturing Practice (GMP) Guidelines
• 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals
• ICH Q7 – Good Manufacturing Practice for Active Pharmaceutical Ingredients

9. SOP Version

Version: 2.0

10. Approval Section

11. Annexures

Annexure 1: Raw Material Receipt Log

Annexure 2: Batch Manufacturing Record Template

Annexure 3: Batch Packing Record Template

12. Revision History

Standard Operating Procedure for Maintaining Training Records for Capsule Operators

1. Purpose

The purpose of this SOP is to outline the procedure for maintaining training records for capsule operators. Proper documentation of training activities ensures compliance with GMP, regulatory standards, and the ongoing competence of operators in capsule manufacturing processes.

2. Scope

This SOP applies to all capsule operators at the facility. It covers the process of documenting training activities, including initial training, refresher training, and any additional training specific to capsule manufacturing operations.

3. Responsibilities

• Human Resources (HR) Department: Responsible for scheduling training programs, maintaining training records, and ensuring compliance with training requirements.
• Production Supervisors: Responsible for ensuring that operators receive the required training and that their performance is evaluated post-training.
• Quality Assurance (QA) Team: Responsible for reviewing training records to ensure that all training activities are documented and compliant with GMP standards.
• Operators: Responsible for attending all training sessions as scheduled and demonstrating competency in their tasks following training.

4. Accountability

The Production Manager is accountable for ensuring that operators receive the required training and that training records are maintained. The HR Manager is responsible for organizing and archiving training records, ensuring compliance with training requirements.

5. Procedure

5.1 Identifying Training Needs

Training needs for capsule operators should be identified as follows:

1. Initial Training
   1. New operators must undergo training on all relevant capsule manufacturing processes, equipment, and safety procedures before being allowed to perform any tasks.
   2. The training must include both theoretical knowledge and practical demonstrations on equipment and process handling.
2. Refresher Training
   1. Operators must undergo periodic refresher training on GMP, equipment operation, and process updates as per the training schedule.
   2. Refresher training should be done at least annually, or as needed based on any changes in processes, equipment, or regulatory requirements.
3. Specialized Training
   1. Specialized training may be required when new equipment or processes are introduced or when an operator’s performance is deemed unsatisfactory.

5.2 Scheduling Training Sessions

Once the training needs have been identified, the following steps should be followed:

1. Coordinate Training Schedules
   1. The HR team will schedule training sessions, considering the availability of trainers, training materials, and operators.
   2. Ensure that training sessions do not disrupt ongoing production schedules.
2. Notify Operators
   1. Operators must be notified in advance of scheduled training, including the objectives, location, and duration of the session.

5.3 Conducting Training

Follow these steps during the training session:

1. Prepare Training Materials
   1. Ensure that all necessary training materials, including presentations, manuals, and equipment, are prepared and available.
   2. Materials must be up to date and aligned with current GMP standards and production procedures.
2. Conduct the Training
   1. The training should be conducted by a qualified trainer with practical knowledge of capsule production processes.
   2. Training should be interactive, with demonstrations and opportunities for questions and discussions.

5.4 Documenting Training

After the training session, follow these steps to document the training:

1. Training Record
   1. Record the details of each training session, including the date, trainer’s name, topics covered, and names of participants.
   2. Document whether the operator successfully completed the training and any areas requiring further attention or follow-up training.
2. Operator Sign-off
   1. Each operator must sign the training record to confirm their attendance and understanding of the training material.
   2. If any operator misses a session, they must complete the training at the earliest opportunity.
3. Record Storage
   1. All training records must be securely stored in both physical and electronic formats, ensuring that they are accessible for audits and regulatory inspections.

5.5 Reviewing and Updating Training Records

The HR and QA teams must periodically review and update training records as follows:

1. Review Training Effectiveness
   1. Conduct periodic assessments of the operators’ skills and knowledge to verify that the training has been effective.
   2. Evaluate operator performance and retrain if necessary.
2. Update Training Records
   1. Update training records to reflect any new training completed, including refresher courses, new processes, or equipment training.

6. Abbreviations

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

7. Documents

1. Annexure 1: Training Record Template
2. Annexure 2: Training Attendance Log
3. Annexure 3: Training Effectiveness Evaluation Form

8. References

• Good Manufacturing Practice (GMP) Guidelines
• 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals
• ISO 9001:2015 – Quality Management Systems

9. SOP Version

Version: 2.0

10. Approval Section

11. Annexures

Annexure 1: Training Record Template

Annexure 2: Training Attendance Log

Annexure 3: Training Effectiveness Evaluation Form

12. Revision History

Standard Operating Procedure for Documenting QC Test Results for Capsules

1. Purpose

The purpose of this SOP is to establish the procedure for documenting the results of Quality Control (QC) tests performed on capsules. Proper documentation ensures the integrity, traceability, and compliance of test results with regulatory and GMP requirements.

2. Scope

This SOP applies to all QC test results for capsules produced at the facility. It covers the recording, reviewing, and archiving of test results for various tests including, but not limited to, assay, dissolution, hardness, and microbial testing.

3. Responsibilities

• Quality Control (QC) Team: Responsible for performing all QC tests on capsules, documenting results accurately, and ensuring that all necessary details are recorded in the test logbooks or electronic systems.
• Quality Assurance (QA) Team: Ensures that test results are reviewed and verified for compliance with specifications and regulatory standards. QA also ensures proper documentation practices are followed.
• Records Management Team: Responsible for archiving QC test results and ensuring they are retrievable for audits and regulatory inspections.

4. Accountability

The QC Manager is accountable for overseeing the documentation of all QC test results and ensuring compliance with this SOP. The QA Manager is responsible for reviewing and approving the test result documentation.

5. Procedure

5.1 Recording QC Test Results

Follow these steps when documenting the results of QC tests on capsules:

1. Perform QC Testing
   1. Perform the required QC tests as per the product specifications and testing protocols, including but not limited to assay, dissolution, hardness, weight variation, and microbial testing.
   2. Ensure that all testing is conducted according to validated methods and in compliance with GMP.
2. Document Test Results
   1. Record the results of each test in the appropriate QC test logbooks or electronic record systems.
   2. Include the test parameters, method used, test conditions, and the observed results. For example, if testing for dissolution, document the time points, test conditions, and the dissolution values observed.
3. Sign and Date Test Records
   1. Ensure that the individual performing the test signs and dates the test results to verify that they were conducted as per SOP and protocol.
   2. If the results are entered electronically, ensure that the system captures the user ID and date for traceability.

5.2 Review of Test Results

Once test results are recorded, the following review process must be followed:

1. Initial Review by QC Team
   1. The QC team member who performed the test must perform an initial review of the results for consistency with product specifications.
   2. If the results are within the defined limits, the QC member should proceed to submit the results for final approval. If the results are out of specification (OOS), they must be flagged for further investigation.
2. Review by QA Team
   1. The QA team will review the documented test results for compliance with GMP and regulatory standards. This review ensures that all necessary details are present and that results are within specified limits.
   2. If any deviations or out-of-specification results are found, QA will investigate the root cause and determine the necessary corrective actions.

5.3 Approval of Test Results

Once the results are reviewed, they must be approved as follows:

1. Final Approval by QA
   1. The QA team is responsible for giving the final approval of test results. Approval signifies that the results are in compliance with product specifications and GMP standards.
   2. Once approved, the test results should be marked as “Approved” in the record and signed off by the QA reviewer.
2. Action for Out-of-Specification Results
   1. If any test results are out of specification, the batch should be put on hold, and the deviation should be documented and investigated (see SOP for Deviations). Corrective actions should be defined and implemented before proceeding with any further testing or release.

5.4 Storing Test Records

Once test results are approved, the following steps should be taken for storing the records:

1. Store Records Securely
   1. Store all QC test records, including raw data, reports, and finalized test results, in a secure and organized manner.
   2. Ensure that records are stored in compliance with GMP and that they are easily retrievable for audits or regulatory inspections.
2. Retain Records for the Required Period
   1. Ensure that QC test records are retained for the period specified by regulatory guidelines (typically 5 years or as required by local regulations).

5.5 Electronic Recordkeeping

If QC test results are documented electronically, the following steps must be followed:

1. Ensure Compliance with 21 CFR Part 11
   1. Ensure that the electronic recordkeeping system complies with 21 CFR Part 11 requirements, including audit trails, data integrity, and user access controls.
   2. Maintain backup copies of all electronic records in case of system failure or data loss.
2. Access Control
   1. Ensure that only authorized personnel can enter or modify QC test results in the electronic record system. Maintain user-specific logins and passwords.

6. Abbreviations

• SOP: Standard Operating Procedure
• GMP: Good Manufacturing Practice
• QC: Quality Control
• QA: Quality Assurance
• CoA: Certificate of Analysis
• BPR: Batch Packing Record

7. Documents

1. Annexure 1: QC Test Results Logbook Template
2. Annexure 2: QC Test Results Review Checklist
3. Annexure 3: Out-of-Specification Report Template

8. References

• Good Manufacturing Practice (GMP) Guidelines
• 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals
• ICH Q7 – Good Manufacturing Practice for Active Pharmaceutical Ingredients

9. SOP Version

Version: 2.0

10. Approval Section

11. Annexures

Annexure 1: QC Test Results Logbook Template

Annexure 2: QC Test Results Review Checklist

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Annexure 3: Out-of-Specification Report Template

12. Revision History

Standard Operating Procedure for Recordkeeping for Stability Studies of Capsules

1. Purpose

The purpose of this SOP is to establish a procedure for recordkeeping of stability studies conducted on capsules. Accurate and detailed recordkeeping ensures that all stability testing data is preserved for regulatory compliance, traceability, and future use.

2. Scope

This SOP applies to all records generated during stability studies of capsules, including test data, analytical results, and packaging conditions. It covers the documentation, storage, and retrieval of stability study records at the facility.

3. Responsibilities

• Quality Control (QC) Team: Responsible for conducting stability testing, documenting the results, and ensuring all data is accurately recorded.
• Quality Assurance (QA) Team: Ensures that stability study records are maintained in compliance with regulatory requirements and company policies.
• Records Management Team: Responsible for organizing and archiving stability study records, ensuring that they are easily accessible for audits and regulatory inspections.
• Research and Development (R&D) Team: Provides input into stability study protocols and ensures that all required information is documented throughout the study period.

4. Accountability

The QA Manager is responsible for overseeing the recordkeeping process and ensuring compliance with this SOP. The QC Manager is responsible for ensuring that stability study records are completed accurately and promptly.

5. Procedure

5.1 Planning and Initiating Stability Studies

Follow these steps when initiating stability studies:

1. Define Stability Study Protocol
   1. Collaborate with the R&D team to develop a stability study protocol that includes the product details, study conditions (e.g., temperature, humidity), and time intervals for testing.
   2. Ensure that the study protocol includes all required testing parameters (e.g., dissolution, assay, appearance) and compliance with regulatory guidelines.
2. Prepare Stability Study Records
   1. Prepare a stability study logbook or electronic record that will track all relevant data for the duration of the study.
   2. Record study start and end dates, testing conditions, and relevant identifiers (e.g., batch numbers, product codes).

5.2 Conducting Stability Tests

During the stability study, follow these steps for testing and documentation:

1. Perform Stability Testing
   1. At each time interval specified in the study protocol, perform the required stability tests (e.g., dissolution, assay, pH, appearance).
   2. Ensure that testing is conducted according to the established methods and that all test parameters are documented.
2. Document Test Results
   1. Record the results of all tests in the stability study logbook or electronic record.
   2. Ensure that results are clearly written or entered, including test conditions, test methods, and any deviations or anomalies observed during testing.

5.3 Review of Stability Data

Follow these steps for reviewing stability study data:

1. Data Review by QC Team
   1. The QC team must review all stability test results for accuracy and compliance with the study protocol.
   2. Ensure that results are compared against the specifications set in the study protocol to determine if the capsules meet stability requirements.
2. Approval by QA Team
   1. The QA team will review the stability study data, including test results and any observed deviations, to ensure compliance with GMP and regulatory standards.
   2. After review, QA will approve the stability study data for inclusion in the final report.

5.4 Final Stability Report and Archiving

Once the stability study is complete, follow these steps for reporting and archiving:

1. Prepare Stability Study Report
   1. Prepare a final stability study report that includes all test results, observations, conclusions, and recommendations.
   2. The report should summarize the data obtained during the study and provide any necessary actions based on the results (e.g., product shelf life determination).
2. Archive Stability Study Records
   1. All stability study records, including raw data, reports, and test results, should be archived in a secure location for future reference and regulatory inspections.
   2. Ensure that records are organized and easily retrievable based on batch number, product type, and study date.
3. Retain Records for Required Period
   1. Stability study records should be retained for the duration required by regulatory guidelines (typically 5 years or as required by local regulations).

6. Abbreviations

• SOP: Standard Operating Procedure
• GMP: Good Manufacturing Practice
• QC: Quality Control
• QA: Quality Assurance
• CoA: Certificate of Analysis
• BPR: Batch Packing Record

7. Documents

1. Annexure 1: Stability Study Logbook Template
2. Annexure 2: Stability Testing Protocol
3. Annexure 3: Final Stability Study Report Template

8. References

• Good Manufacturing Practice (GMP) Guidelines
• 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals
• ICH Q1A – Stability Testing of New Drug Substances and Products

9. SOP Version

Version: 2.0

10. Approval Section

11. Annexures

Annexure 1: Stability Study Logbook Template

Annexure 2: Stability Testing Protocol

Annexure 3: Final Stability Study Report Template

12. Revision History

Standard Operating Procedure for Documentation of Process Deviations in Capsule Production

1. Purpose

The purpose of this SOP is to outline the process for documenting and managing process deviations in capsule production. Ensuring that all deviations are identified, documented, and reviewed helps maintain product quality, safety, and compliance with GMP and regulatory requirements.

2. Scope

This SOP applies to the documentation of any process deviations that occur during the production of capsules, including manufacturing, filling, sealing, and packaging stages. It applies to all personnel involved in capsule production and quality control.

3. Responsibilities

• Production Team: Responsible for identifying and reporting process deviations during production activities.
• Quality Control (QC) Team: Responsible for reviewing the deviation reports and verifying the impact of the deviation on product quality.
• Quality Assurance (QA) Team: Responsible for evaluating deviations, implementing corrective actions, and ensuring proper documentation of the deviation process.
• Deviation Owner: Responsible for investigating the cause of the deviation and ensuring corrective actions are implemented.

4. Accountability

The Production Manager is accountable for ensuring that deviations are promptly identified and reported. The QA Manager is responsible for overseeing the investigation, corrective actions, and ensuring that all deviations are properly documented and reviewed.

5. Procedure

5.1 Identification of Process Deviations

Follow these steps when a process deviation is identified:

1. Monitor Production Activities
   1. Production personnel should continuously monitor manufacturing, filling, and packaging processes for any deviations from standard procedures or specifications.
   2. If any irregularities or non-conformances are observed, the production team must immediately identify the deviation and stop the process if necessary to prevent further impact on the batch.
2. Report Deviation
   1. Immediately report the deviation to the QA team and document the incident in the Deviation Report Log (refer to Annexure 1).
   2. Ensure that the report includes the batch number, product name, the specific deviation observed, and the impact on production.

5.2 Investigation of Deviations

Once a deviation is reported, follow these steps for investigation:

1. Root Cause Investigation
   1. The QA team will work with the production team to investigate the root cause of the deviation. This includes reviewing production records, equipment logs, and raw material information.
   2. Interview relevant personnel and observe the production process to gather additional information related to the deviation.
2. Assess the Impact
   1. The QA team will evaluate the impact of the deviation on product quality and compliance. Determine whether the deviation affects the product’s safety, efficacy, or regulatory status.
   2. If necessary, determine whether the batch should be placed on hold, reworked, or rejected based on the severity of the deviation.

5.3 Corrective and Preventive Actions

After identifying the root cause, implement corrective and preventive actions:

1. Corrective Actions
   1. Develop and implement corrective actions to address the root cause of the deviation and prevent recurrence. Corrective actions may include retraining personnel, adjusting equipment settings, or modifying procedures.
   2. Document corrective actions in the Deviation Report Log and assign responsibility for implementation.
2. Preventive Actions
   1. Implement preventive actions to minimize the risk of similar deviations in the future. Preventive actions may involve revising standard operating procedures (SOPs) or introducing additional controls or checks.
   2. Monitor the effectiveness of preventive actions to ensure they prevent the recurrence of the deviation.

5.4 Documentation and Reporting

Document all process deviations thoroughly:

1. Complete Deviation Report
   1. Ensure that the Deviation Report includes all relevant details, including the deviation description, root cause analysis, corrective and preventive actions, and impact on the batch.
   2. The Deviation Report should be signed off by the QA team and the responsible personnel.
2. Submit to QA for Approval
   1. The completed Deviation Report is submitted to the QA Manager for review and approval. QA will ensure that the deviation is adequately addressed and that the corrective actions are implemented.
3. Store Deviation Records
   1. Store all deviation records in a secure and organized location for future reference and audits.
   2. Ensure that deviation records are retained according to regulatory requirements (typically 5 years or as per local regulations).

5.5 Review and Monitoring

After the corrective actions have been implemented, follow these steps:

1. Monitor Effectiveness
   1. Monitor the effectiveness of corrective actions to ensure that the deviation does not recur.
   2. Conduct periodic reviews of deviations to identify any recurring issues or patterns that may require further corrective actions.
2. Periodic Audits
   1. Conduct regular audits of the deviation process to ensure compliance with this SOP and regulatory requirements.
   2. Ensure that all deviations are documented and reviewed in a timely manner.

6. Abbreviations

• SOP: Standard Operating Procedure
• GMP: Good Manufacturing Practice
• QA: Quality Assurance
• QC: Quality Control
• BMR: Batch Manufacturing Record
• CoA: Certificate of Analysis

7. Documents

1. Annexure 1: Deviation Report Template
2. Annexure 2: Corrective Action Plan
3. Annexure 3: Root Cause Analysis Template

8. References

• Good Manufacturing Practice (GMP) Guidelines
• 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals
• ICH Q7 – Good Manufacturing Practice for Active Pharmaceutical Ingredients

9. SOP Version

Version: 2.0

10. Approval Section

11. Annexures

Annexure 1: Deviation Report Template

Annexure 2: Corrective Action Plan

Annexure 3: Root Cause Analysis Template

12. Revision History

Standard Operating Procedure for Maintaining Cleaning Logs for Capsule Equipment

1. Purpose

The purpose of this SOP is to define the procedure for maintaining cleaning logs for capsule manufacturing equipment. The cleaning logs ensure that all equipment used in the production of capsules is thoroughly cleaned, documented, and compliant with Good Manufacturing Practices (GMP).

2. Scope

This SOP applies to all capsule manufacturing equipment that requires cleaning, including but not limited to capsule filling machines, sealing machines, and granulation equipment. It covers the procedure for documenting cleaning activities to ensure equipment hygiene and GMP compliance.

3. Responsibilities

• Production Team: Responsible for performing cleaning procedures on equipment and maintaining accurate cleaning logs.
• Quality Control (QC) Team: Responsible for reviewing cleaning logs to ensure that cleaning procedures are followed correctly.
• Quality Assurance (QA) Team: Responsible for approving and ensuring that the cleaning logs are maintained according to GMP and regulatory standards.
• Maintenance Team: Responsible for ensuring that cleaning equipment (e.g., washers) is properly maintained and operational.

4. Accountability

The Production Manager is accountable for ensuring that cleaning procedures are followed and that cleaning logs are properly maintained. The QA Manager is responsible for approving and auditing cleaning logs to ensure compliance with GMP.

5. Procedure

5.1 Preparing for Cleaning

Follow these steps before cleaning the equipment:

1. Ensure Equipment is Disassembled (if required)
   1. Disassemble any removable parts of the equipment (e.g., hopper bins, feeders, and nozzles) to facilitate thorough cleaning.
   2. Verify that all parts that come into direct contact with the product are accessible for cleaning.
2. Ensure Availability of Cleaning Materials
   1. Ensure that all necessary cleaning materials, such as cleaning agents, brushes, wipes, and water, are available and in sufficient quantities.
   2. Confirm that the cleaning agents used are approved for the intended purpose and are compliant with GMP guidelines.

5.2 Cleaning Procedure

Follow the cleaning procedure outlined below:

1. Clean Equipment Thoroughly
   1. Use appropriate cleaning agents, tools, and methods to clean the equipment, ensuring that all product residues, contaminants, and debris are removed.
   2. Ensure that the cleaning process includes areas that are in direct contact with the capsule fill material and any other exposed surfaces.
2. Rinse and Dry
   1. After cleaning, rinse the equipment with water to remove any cleaning agents, ensuring that no residues are left behind.
   2. Dry all cleaned components thoroughly, using appropriate methods (e.g., air drying, clean cloths), to prevent microbial growth.
3. Inspect Equipment
   1. Visually inspect the equipment after cleaning to ensure that it is completely clean and free from contaminants.
   2. Check for any damage to parts during cleaning or assembly that may require maintenance or replacement.

5.3 Recording Cleaning Activities

It is critical to document each cleaning activity performed on the equipment. Follow these steps:

1. Fill Out the Cleaning Log
   1. Record the following details in the cleaning log:
      • Date and time of cleaning
      • Batch number or product name cleaned
      • Equipment cleaned
      • Cleaning agents used
      • Personnel performing the cleaning
      • Inspection results (i.e., equipment condition after cleaning)
2. Signatures
   1. The personnel who performed the cleaning must sign and date the cleaning log to confirm the completion of the activity.
   2. The QA team must review and sign off on the cleaning log to ensure that all cleaning procedures have been followed and documented appropriately.

5.4 Cleaning Log Review and Storage

Once the cleaning logs are completed, follow the steps below:

1. Review Cleaning Logs
   1. The QA team must review the cleaning logs for completeness and accuracy, ensuring all required details are recorded.
   2. If any discrepancies or deviations are found, they must be investigated, and corrective actions should be taken.
2. Store Cleaning Logs
   1. Once reviewed and approved, store the cleaning logs in a secure and organized location for easy retrieval during audits and inspections.
   2. Ensure that the logs are stored for the required retention period as per regulatory guidelines (typically 5 years).

6. Abbreviations

• SOP: Standard Operating Procedure
• GMP: Good Manufacturing Practice
• QC: Quality Control
• QA: Quality Assurance
• CoA: Certificate of Analysis

7. Documents

1. Annexure 1: Cleaning Log Template
2. Annexure 2: Equipment Inspection Checklist
3. Annexure 3: Approved Cleaning Agent List

8. References

• Good Manufacturing Practice (GMP) Guidelines
• 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals
• ICH Q7 – Good Manufacturing Practice for Active Pharmaceutical Ingredients

9. SOP Version

Version: 2.0

10. Approval Section

11. Annexures

Annexure 1: Cleaning Log Template

Annexure 2: Equipment Inspection Checklist

Annexure 3: Approved Cleaning Agent List

12. Revision History

Standard Operating Procedure for Preparing Batch Packing Records for Capsules

1. Purpose

The purpose of this SOP is to define the procedure for preparing Batch Packing Records (BPRs) for capsules. The BPR ensures that all packaging steps, materials, and processes are documented and compliant with GMP and regulatory requirements.

2. Scope

This SOP applies to the preparation of Batch Packing Records for all batches of capsules produced at the facility. It includes the documentation of all packaging activities, including the materials used, packaging equipment, and batch labeling.

3. Responsibilities

• Packaging Team: Responsible for completing the BPR during the capsule packaging process and ensuring that all packaging details are documented accurately.
• Quality Control (QC) Team: Ensures that the BPR is reviewed for accuracy and completeness before batch release.
• Quality Assurance (QA) Team: Reviews and approves the BPR to ensure compliance with GMP and regulatory standards.

4. Accountability

The Packaging Manager is accountable for overseeing the BPR preparation process. The QA Manager is responsible for reviewing and approving the BPR before the batch is released for distribution.

5. Procedure

5.1 Preparation of Batch Packing Record

Follow the steps below to prepare the BPR:

1. Review Batch Information
   1. Obtain the batch number, product specifications, and batch size from the Production team.
   2. Verify that the batch size is consistent with the manufacturing order and production plan.
2. Document Packaging Materials
   1. List all packaging materials used, including bottles, blister packs, foil, and labels.
   2. Ensure that the batch numbers, supplier information, and quantities of packaging materials are recorded in the BPR.
3. Record Packaging Process Details
   1. Document the packaging steps, including the type of packaging used (e.g., blister packs, bottles), machine settings, and packaging equipment used during the process.
   2. Ensure that the number of capsules packed, and the packaging line speed, are accurately recorded.
4. Include Labeling Information
   1. Document the details of labeling, including the batch number, product name, manufacturing date, expiry date, and regulatory markings.
   2. Verify that the correct labels are applied to the packaging and that they comply with regulatory requirements.
5. Include In-Process Checkpoints
   1. Record any in-process quality checks performed during the packaging process, such as checking for labeling accuracy, filling levels, or package integrity.
   2. If any issues are detected, document the corrective actions taken.

5.2 Review of Batch Packing Record

Once the BPR is completed, the following review process must be followed:

1. Review by Packaging Team
   1. The Packaging team must review the BPR for completeness and accuracy. Verify that all necessary details are recorded, and that the batch number, packaging materials, and process steps are consistent.
2. Review by Quality Control
   1. The QC team reviews the BPR for accuracy, ensuring that in-process quality checks have been recorded and that all packaging materials meet specifications.
   2. Ensure that any deviations are documented and appropriate corrective actions are noted.
3. Approval by Quality Assurance
   1. The QA team reviews the BPR to ensure compliance with GMP and regulatory requirements.
   2. The QA team will approve the BPR, indicating that the batch is ready for release.

5.3 Batch Record Storage and Archiving

Once the BPR is reviewed and approved, ensure the following steps:

1. Store BPR
   1. Store the BPR in a secure location, either digitally or physically, according to the company’s record-keeping policies.
   2. Ensure that the BPR is stored in an organized and easily accessible manner for future reference or audits.
2. Maintain Records for Audits
   1. Ensure that the BPR is available for internal and external audits, as required by regulatory authorities.
   2. Ensure that records are retained for the required period (usually 5 years or as per local regulations).

6. Abbreviations

• SOP: Standard Operating Procedure
• GMP: Good Manufacturing Practice
• BPR: Batch Packing Record
• QA: Quality Assurance
• QC: Quality Control
• CoA: Certificate of Analysis

7. Documents

1. Annexure 1: Batch Packing Record Template
2. Annexure 2: Packaging Material Log
3. Annexure 3: In-Process Quality Check Record

8. References

• Good Manufacturing Practice (GMP) Guidelines
• 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals
• ICH Q7 – Good Manufacturing Practice for Active Pharmaceutical Ingredients

9. SOP Version

Version: 2.0

10. Approval Section

11. Annexures

Annexure 1: Batch Packing Record Template

Annexure 2: Packaging Material Log

Annexure 3: In-Process Quality Check Record

12. Revision History

Standard Operating Procedure for Archiving Capsule Manufacturing Records

1. Purpose

The purpose of this SOP is to establish a procedure for the proper archiving of capsule manufacturing records to ensure that all records are stored, maintained, and readily accessible for future reference, audits, and regulatory inspections.

2. Scope

This SOP applies to all records related to the manufacturing of capsules, including Batch Manufacturing Records (BMRs), in-process testing results, and packaging records. It covers the process of archiving these records in a secure and organized manner.

3. Responsibilities

• Quality Control (QC) Team: Responsible for ensuring that all manufacturing records are reviewed, approved, and properly archived in accordance with the company’s record-keeping policies.
• Production Team: Responsible for providing accurate and complete manufacturing records to the QC team for archiving after the production process is completed.
• Quality Assurance (QA) Team: Responsible for ensuring compliance with regulatory and company requirements for record archiving, and for reviewing archived records during audits.
• Records Management Team: Responsible for the physical or digital storage of records and ensuring their security and accessibility.

4. Accountability

The QC Manager is accountable for overseeing the archiving process and ensuring that all manufacturing records are appropriately archived. The Records Management Team is responsible for the actual storage and retrieval of the archived records.

5. Procedure

5.1 Preparation of Manufacturing Records for Archiving

Before archiving, ensure the following steps are completed:

1. Review Manufacturing Records
   1. The QC team reviews all manufacturing records, including the BMR, in-process testing data, and packaging information, to ensure completeness and accuracy.
   2. Ensure that all required signatures and dates are present, and verify that there are no missing documents or discrepancies.
2. Compile Required Documents
   1. Ensure that all relevant records are included in the batch file for archiving, including raw material information, in-process testing data, and packaging and labeling details.
   2. For digital records, ensure that all files are properly named, labeled, and organized according to the batch number and product type.

5.2 Archiving Process

Follow the procedure for archiving records:

1. Store Physical Records
   1. For paper records, ensure that they are stored in a secure location, such as a locked filing cabinet or archive room, with limited access to authorized personnel only.
   2. Organize records by batch number and production date to facilitate easy retrieval.
2. Store Digital Records
   1. For digital records, ensure that they are stored in a secure, backed-up electronic system or cloud-based storage that complies with data security protocols.
   2. Ensure that digital files are clearly named and stored in appropriate folders for easy access.
3. Ensure Long-Term Storage
   1. Records should be stored for the minimum retention period as required by regulatory authorities (typically 5 years or as per local regulations).
   2. Ensure that both physical and digital records are protected from damage, loss, or unauthorized access.

5.3 Record Retrieval and Access

When accessing archived records, follow these procedures:

1. Request for Records
   1. To retrieve archived records, submit a formal request to the Records Management team or through the digital system for access to the required documents.
   2. Ensure that the request specifies the batch number, product, and the specific records required (e.g., BMR, testing results, packaging data).
2. Access Approval
   1. Access to archived records must be authorized by the appropriate personnel (e.g., QC or QA Manager), particularly for sensitive or confidential data.
3. Retrieve Records
   1. Once access is approved, retrieve the physical or digital records from the designated storage area and provide them to the requesting department.
   2. Ensure that the records are returned to their proper storage location after use to maintain the organization of archived documents.

5.4 Deletion or Disposal of Records

Follow these steps when it is time to dispose of or delete records:

1. Determine Retention Period
   1. Ensure that records are kept for the required retention period as per regulatory guidelines (usually 5 years or as specified in the stability study protocols).
   2. At the end of the retention period, evaluate whether the records are still required for operational or legal purposes.
2. Delete or Dispose of Records
   1. For digital records, ensure proper deletion from the storage system or secure destruction, with verification that the records are no longer accessible.
   2. For physical records, ensure that the documents are securely shredded or destroyed in a manner that prevents unauthorized access to sensitive data.

6. Abbreviations

• SOP: Standard Operating Procedure
• GMP: Good Manufacturing Practice
• BMR: Batch Manufacturing Record
• QA: Quality Assurance
• QC: Quality Control
• CoA: Certificate of Analysis

7. Documents

1. Annexure 1: Batch Manufacturing Record (BMR) Template
2. Annexure 2: Record Retention Log
3. Annexure 3: Record Disposal Certificate

8. References

• Good Manufacturing Practice (GMP) Guidelines
• 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals
• ICH Q7 – Good Manufacturing Practice for Active Pharmaceutical Ingredients

9. SOP Version

Version: 2.0

10. Approval Section

11. Annexures

Annexure 1: Batch Manufacturing Record (BMR) Template

Annexure 2: Record Retention Log

Annexure 3: Record Disposal Certificate

12. Revision History

Standard Operating Procedure for Reviewing Batch Manufacturing Records (BMRs)

1. Purpose

The purpose of this SOP is to define the procedure for reviewing Batch Manufacturing Records (BMRs) for capsules. This ensures that all manufacturing processes have been conducted in compliance with Good Manufacturing Practices (GMP) and regulatory requirements.

2. Scope

This SOP applies to the review process of BMRs for all capsule production batches. It includes verifying the accuracy of the recorded data, ensuring compliance with manufacturing protocols, and confirming that all necessary documents are complete and accurate.

3. Responsibilities

• Quality Control (QC) Team: Responsible for performing the review of the BMR, ensuring all manufacturing steps, materials, and quality control measures are accurately documented and compliant with internal and regulatory standards.
• Production Team: Responsible for ensuring that the BMR is completed accurately during the manufacturing process and is submitted to the QC team for review.
• Quality Assurance (QA) Team: Responsible for the final approval of the reviewed BMR and ensuring that the batch meets the required quality standards for release.

4. Accountability

The QC Manager is accountable for overseeing the BMR review process. The QA Manager is responsible for the final approval of the BMR before the batch is released for further processing or distribution.

5. Procedure

5.1 Review of BMR Submission

Before starting the review process, ensure the following:

1. Receive Completed BMR
   1. Ensure that the BMR has been fully completed by the Production team, including all necessary details such as batch number, raw materials, and manufacturing steps.
   2. Confirm that all sections of the BMR are signed and dated by the relevant personnel (e.g., production operators, quality control inspectors).
2. Verify Batch Information
   1. Ensure that the batch number, product name, and production dates are accurately recorded in the BMR.
   2. Verify that the batch size is consistent with the manufacturing order and production plan.
3. Check Raw Material Documentation
   1. Ensure that all raw materials used in the batch are correctly listed in the BMR with corresponding batch numbers, quantities used, and supplier details.
   2. Verify that the Certificate of Analysis (CoA) for each raw material is available and meets the required specifications.

5.2 In-Process Documentation Review

Review the documentation for in-process controls and manufacturing steps:

1. Check Manufacturing Process Documentation
   1. Verify that all manufacturing steps are documented and correspond to the approved process, including granulation, mixing, filling, and sealing.
   2. Ensure that any deviations from the approved manufacturing process are documented with appropriate explanations and corrective actions.
2. Review In-Process Testing Data
   1. Ensure that all in-process testing results, such as weight variation, dissolution, disintegration, and content uniformity, are accurately documented and meet the specifications.
   2. If any tests fail to meet specifications, ensure that the deviation has been addressed and corrective actions have been taken.

5.3 Review of Packaging Information

Ensure that all packaging details are correctly documented:

1. Check Packaging Information
   1. Verify that the type of packaging used (e.g., bottles, blister packs, foil pouches) is recorded accurately in the BMR.
   2. Ensure that the quantity of capsules packed and labeled is consistent with the batch size and production plan.
2. Ensure Correct Labeling
   1. Check that the labels used on the packaging include the correct batch number, product name, manufacturing date, expiry date, and any required regulatory information.

5.4 Final Review and Approval

Once the BMR has been thoroughly reviewed, proceed with the following steps:

1. Verify Compliance
   1. Ensure that the entire BMR is in compliance with GMP guidelines and regulatory requirements.
   2. Verify that the necessary signatures from the production, quality control, and quality assurance personnel are obtained.
2. Approval
   1. The QA team must approve the BMR for the batch to be released for further processing or distribution.
   2. Ensure that the approved BMR is stored according to the company’s record-keeping policies.

5.5 Documentation and Archiving

Once the BMR is approved, it must be properly archived:

1. Store BMRs
   1. Ensure that the BMR is stored in a secure location, where it can be easily accessed for future reference or audit purposes.
   2. Maintain BMRs for a period as required by regulatory authorities (typically 5 years).
2. Archive for Audits
   1. Ensure that BMRs are available for internal and external audits, as required by regulatory bodies.
   2. Ensure that any discrepancies or non-conformities are addressed prior to archiving.

6. Abbreviations

• SOP: Standard Operating Procedure
• GMP: Good Manufacturing Practice
• BMR: Batch Manufacturing Record
• QA: Quality Assurance
• QC: Quality Control
• CoA: Certificate of Analysis

7. Documents

1. Annexure 1: Batch Manufacturing Record Template
2. Annexure 2: In-Process Testing Record
3. Annexure 3: Deviation Report

8. References

• Good Manufacturing Practice (GMP) Guidelines
• 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals
• ICH Q7 – Good Manufacturing Practice for Active Pharmaceutical Ingredients

9. SOP Version

Version: 2.0

10. Approval Section

11. Annexures

Annexure 1: Batch Manufacturing Record Template

Annexure 2: In-Process Testing Record

Annexure 3: Deviation Report

12. Revision History