Standard Operating Procedure for Dispensing Light Sensitive Materials in Elixir Manufacturing

1. Purpose

To establish a standardized procedure for the accurate and GMP-compliant dispensing of light-sensitive materials used in the manufacturing of elixir formulations, ensuring protection from light exposure and preserving material integrity.

2. Scope

This SOP is applicable to all light-sensitive raw materials such as ascorbic acid, riboflavin, retinol, and similar ingredients that degrade or lose potency upon exposure to light, used in the Elixir Department.

3. Responsibilities

• Dispensing Operator:
  • Dispense materials under low-light conditions or using protective shielding.
  • Ensure containers are handled and re-sealed promptly.
• Warehouse Supervisor:
  • Ensure materials are stored in light-protective containers or amber bottles.
• QA Officer:
  • Verify that dispensing has occurred under suitable light-protected conditions and approve the release of the material.

4. Accountability

The Production Head and QA Manager are accountable for enforcing and monitoring the dispensing process of light-sensitive materials in accordance with this SOP and applicable regulatory standards.

5. Procedure

5.1 Material Verification

1. Review the material status on the Material Requisition Form and Batch Manufacturing Record (BMR).
2. Confirm that the material is labeled “Light Sensitive” and stored in a protective container.
3. Check for:
   • Intact amber glass/plastic container or opaque cover
   • Proper labeling with batch number and expiry date
   • Green “Approved” status label

5.2 Preparation for Dispensing

1. Transfer the material to the designated low-light dispensing area.
2. Cover fluorescent or LED lights with yellow sleeves or switch off unnecessary lights.
3. Ensure the weighing balance is pre-calibrated and tared with covered containers.

5.3 Dispensing Activity

1. Minimize the exposure of the material to direct light.
2. Use light-protective tools and amber-colored or foil-wrapped weighing containers.
3. Weigh the required quantity as per BMR using covered balance pans.
4. Immediately transfer dispensed material to amber-colored containers with lids or wrap with aluminum foil.
5. Label the container and place in a light-shielded storage tray until transferred to production.

5.4 Documentation

1. Record the following in the Material Dispensing Log (Annexure-1):
   • Material Name
   • Batch Number
   • Quantity Dispensed
   • Light Conditions Used
   • Dispensed By / Verified By
2. Attach the Certificate of Analysis (Annexure-2) and complete the Approval and Release Form (Annexure-3).

5.5 Return and Storage of Excess

1. Return remaining material to the warehouse immediately in its original light-protected container.
2. Record returned quantity and verify light-protective measures were maintained.

6. Abbreviations

• BMR: Batch Manufacturing Record
• QA: Quality Assurance
• SOP: Standard Operating Procedure

7. Documents

1. Material Dispensing Log (Annexure-1)
2. Certificate of Analysis (Annexure-2)
3. Approval and Release Form (Annexure-3)

8. References

• 21 CFR Part 211 – Current Good Manufacturing Practice
• WHO TRS 986 Annex 2 – GMP for Pharmaceutical Products

9. SOP Version

Version: 2.0

10. Approval Section

11. Annexures

Annexure-1: Material Dispensing Log

Annexure-2: Certificate of Analysis (CoA)

Annexure-3: Approval and Release Form

Revision History:

Standard Operating Procedure for Dispensing Humidity Sensitive Materials in Elixir Manufacturing

1. Purpose

This SOP outlines the procedure for the safe and controlled dispensing of humidity-sensitive raw materials in the Elixir Department, ensuring product stability, integrity, and GMP compliance.

2. Scope

This SOP applies to all activities involving the dispensing of hygroscopic or moisture-sensitive raw materials and excipients, including but not limited to citric acid, sorbitol, sodium citrate, and ascorbic acid.

3. Responsibilities

• Dispensing Operator:
  • Ensure dispensing is done in humidity-controlled areas and record environmental data.
  • Use proper tools and containers for handling sensitive materials.
• Warehouse Supervisor:
  • Ensure materials are stored in sealed containers and monitored for humidity exposure.
• QA Officer:
  • Verify environmental conditions and documentation before releasing materials.

4. Accountability

The Production Head and Warehouse In-Charge are jointly accountable for ensuring that all humidity-sensitive materials are dispensed as per this SOP and maintained under appropriate environmental conditions.

5. Procedure

5.1 Identification and Preparation

1. Identify materials labeled as “Humidity Sensitive” or “Hygroscopic” as per the approved material list.
2. Ensure containers are intact, sealed, and labeled with storage condition details.
3. Transfer materials to the dispensing booth with relative humidity (RH) below 35%.

5.2 Environmental Control Verification

1. Verify RH using a calibrated hygrometer before starting dispensing.
2. Record RH value in the Dispensing Log (Annexure-1) and ensure it is within specified limits.
3. Proceed only if RH is ≤ 35%; otherwise, delay dispensing until conditions are met.

5.3 Dispensing Activity

1. Open the container quickly and carefully. Avoid exposure to open air for more than 2 minutes at a time.
2. Weigh the material using pre-cleaned tools and place in airtight containers immediately after dispensing.
3. Seal and label both the dispensed and original containers promptly.

5.4 Labeling and Documentation

1. Label the dispensed material with:
   • Material Name
   • Batch Number
   • Quantity Dispensed
   • RH During Dispensing
   • Date
   • Dispensed By / Verified By
2. Record RH, dispensing time, and exposure duration in the logbook.

5.5 Storage and Return

1. Return unused material to desiccator-equipped storage or a low RH zone within 30 minutes.
2. Record returned quantity and time in the Material Return Register.

6. Abbreviations

• RH: Relative Humidity
• QA: Quality Assurance
• SOP: Standard Operating Procedure

7. Documents

1. Humidity-Sensitive Material Dispensing Log (Annexure-1)
2. Certificate of Analysis (Annexure-2)
3. Approval and Release Form (Annexure-3)

8. References

• WHO TRS 986 Annex 2 – GMP Guidelines
• 21 CFR Part 211 – GMP for Finished Pharmaceuticals

9. SOP Version

Version: 2.0

10. Approval Section

11. Annexures

Annexure-1: Humidity-Sensitive Material Dispensing Log

Annexure-2: Certificate of Analysis (CoA)

Annexure-3: Approval and Release Form

Revision History:

Standard Operating Procedure for Dispensing of Preservatives in Elixir Formulations

1. Purpose

To establish a standard procedure for the safe, accurate, and contamination-free dispensing of preservatives used in the manufacturing of oral elixirs. This SOP ensures the correct quantity and handling of preservatives to maintain product stability and microbial control.

2. Scope

This SOP is applicable to all activities related to the dispensing of preservatives such as methylparaben, propylparaben, sodium benzoate, potassium sorbate, and similar agents used in the Elixir Department.

3. Responsibilities

• Dispensing Operator:
  • Carry out dispensing of preservatives as per batch requirement and record the activity.
• Supervisor:
  • Verify material identity, batch number, and quantity before and after dispensing.
• QA Officer:
  • Ensure documentation is complete and approve materials for release to manufacturing.

4. Accountability

The Production Head is accountable for implementation and adherence to this SOP and ensuring that preservatives are dispensed accurately and documented properly.

5. Procedure

5.1 Material Verification

1. Check the Material Requisition Form (MRF) and Batch Manufacturing Record (BMR) for the exact name, quantity, and batch number of the required preservative.
2. Ensure the container has a green “Approved” status label and is within expiry.
3. Confirm container integrity and label details:
   • Material Name
   • Batch Number
   • Manufacturing and Expiry Dates

5.2 Dispensing Procedure

1. Transfer the container to the dispensing booth or laminar airflow (LAF) area.
2. Clean the container exterior with 70% IPA and dry it before opening.
3. Use pre-cleaned stainless steel scoops or dispensers for solid preservatives; use calibrated pipettes or measuring cylinders for liquid preservatives.
4. Weigh the required quantity using a calibrated balance and record the reading.
5. Seal the original container tightly and label it as “Partially Used – To be Returned”.

5.3 Labeling and Recording

1. Label the dispensed container with:
   • Material Name
   • Batch Number
   • Quantity Dispensed
   • Date
   • Dispensed By and Verified By
2. Make entries in the Material Dispensing Log (Annexure-1) and initial the BMR.

5.4 Quality Check and Release

1. The QA officer shall:
   • Review documentation and physical container.
   • Approve the use of the dispensed preservative by signing the Approval Form.
2. Release the dispensed material to production upon approval.

5.5 Storage and Return of Excess

1. Return the unused preservative to the warehouse with a filled Material Return Form.
2. Store the returned material in designated “Approved – Partially Used” storage with controlled conditions.

6. Abbreviations

• QA: Quality Assurance
• SOP: Standard Operating Procedure
• BMR: Batch Manufacturing Record
• IPA: Isopropyl Alcohol

7. Documents

1. Material Dispensing Log (Annexure-1)
2. Certificate of Analysis (Annexure-2)
3. Approval and Release Form (Annexure-3)

8. References

• 21 CFR Part 211 – Good Manufacturing Practice
• WHO TRS 986 Annex 2 – GMP Guidelines

9. SOP Version

Version: 2.0

10. Approval Section

11. Annexures

Annexure-1: Material Dispensing Log

Annexure-2: Certificate of Analysis (CoA)

Annexure-3: Approval and Release Form

Revision History:

Standard Operating Procedure for Double Check System During Dispensing of Materials

1. Purpose

This SOP establishes the procedure for implementing a Double Check System during the dispensing of raw materials, excipients, and solvents in the Elixir Department. It ensures that dispensing is carried out with full accuracy, traceability, and regulatory compliance, reducing the risk of human error.

2. Scope

This SOP applies to all materials dispensed for elixir manufacturing processes and must be followed by the designated dispensing operator and verifying personnel involved in material handling and weighing.

3. Responsibilities

• Dispensing Operator:
  • Perform the initial dispensing activity and fill out the required documentation.
  • Ensure readiness for second-person verification.
• Second Verifier (Supervisor or Authorized Personnel):
  • Verify material name, batch number, weight, container label, and documentation entries.
  • Sign the verification section on the dispensing log and BMR.
• QA Officer:
  • Periodically audit double check entries and approve completeness of documentation.

4. Accountability

The Production Head is accountable for enforcing this SOP and ensuring that no material is released for manufacturing without completion of double verification during dispensing.

5. Procedure

5.1 Preparation Before Dispensing

1. Ensure the dispensing booth, balance, and accessories are clean and calibrated.
2. Verify the approved status of the raw material and confirm storage conditions.
3. Prepare dispensing logbook and relevant BMR page for real-time entry and signature.

5.2 First-Person Activity

1. The dispensing operator shall:
   • Identify the material and verify label details.
   • Weigh the material as per the batch requirement.
   • Record the following:
     • Material Name
     • Batch Number
     • Weighed Quantity
     • Date
     • Sign and mention time of activity

5.3 Second-Person Verification

1. The verifier shall:
   • Cross-check the material label against the entry in the dispensing log.
   • Verify the actual weight using the same calibrated balance.
   • Ensure the container has been sealed and labeled properly after dispensing.
   • Sign the double check section of the dispensing log and mark date/time of verification.

5.4 Documentation and Labeling

1. Affix “Double Checked” status label on each dispensed container with initials of both personnel.
2. All entries in the dispensing log must be verified before transferring material to production.

5.5 Exception Handling

1. If a discrepancy is found during verification:
   • Stop further processing and inform QA immediately.
   • Document the deviation using the standard Deviation Form.
   • Retain the material in a segregated area until disposition is authorized.

6. Abbreviations

• BMR: Batch Manufacturing Record
• QA: Quality Assurance
• SOP: Standard Operating Procedure

7. Documents

1. Material Dispensing Log with Verification Section (Annexure-1)
2. Double Checked Container Label Format (Annexure-2)
3. Deviation Reporting Form (Annexure-3)

8. References

• WHO GMP Guidelines – Pharmaceutical Production
• 21 CFR Part 211 – Current GMP for Finished Pharmaceuticals

9. SOP Version

Version: 2.0

10. Approval Section

11. Annexures

Annexure-1: Material Dispensing Log with Verification Section

Annexure-2: Double Checked Container Label

Annexure-3: Deviation Reporting Form

Revision History:

Standard Operating Procedure for Handling Return of Materials after Dispensing in Elixir Manufacturing

1. Purpose

This SOP outlines the procedure for managing returned materials after partial dispensing during elixir manufacturing. It ensures proper handling, identification, storage, and documentation of returned raw materials to maintain their quality and traceability.

2. Scope

This SOP applies to all returned raw materials, excipients, and solvents that remain unused after dispensing operations in the Elixir Department and are returned to the warehouse or storage area.

3. Responsibilities

• Dispensing Operator:
  • Return unused material immediately after dispensing with intact labeling and seals.
• Warehouse Staff:
  • Verify the return condition and quantity, and reassign proper storage location.
• QA Personnel:
  • Inspect and approve return for reuse or recommend rejection.
  • Maintain return records and ensure traceability.

4. Accountability

The Warehouse In-Charge is accountable for ensuring that returned materials are handled as per this SOP and comply with GMP and traceability requirements.

5. Procedure

5.1 Immediate Return after Dispensing

1. After completing dispensing, the operator shall seal the remaining material using its original closure system.
2. Label the container with a “Returned Material” tag, including:
   • Material Name
   • Batch Number
   • Returned Quantity
   • Date
   • Dispensing Reference Number
3. Submit the material along with the filled Material Return Slip to the warehouse.

5.2 Warehouse Verification

1. Warehouse personnel shall:
   • Verify physical integrity of the container and seal.
   • Cross-check quantity returned with the dispensing logbook.
   • Confirm labeling and accompanying documentation.
2. Reject the material if there are signs of tampering, contamination, or labeling discrepancies.

5.3 Quality Assurance Review

1. QA shall:
   • Inspect the condition of the returned material.
   • Determine if the material is reusable based on visual and documented review.
   • Approve or reject the material by signing the Return Slip and recording the decision.

5.4 Storage and Status Update

1. Store approved returned material in its original storage conditions with proper identification label (e.g., “Partially Used – Approved”).
2. Update the inventory control system with the returned quantity and status.
3. Rejected materials should be moved to the “Rejected Area” and documented in the Non-Conformance Register.

5.5 Documentation

1. Record details of returned materials in the Material Return Register (Annexure-1).
2. Attach a copy of the Certificate of Analysis (CoA) if required by QA (Annexure-2).
3. Maintain the Return Approval Form signed by QA (Annexure-3).

6. Abbreviations

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

7. Documents

1. Material Return Register (Annexure-1)
2. Certificate of Analysis (Annexure-2)
3. Return Approval Form (Annexure-3)

8. References

• 21 CFR Part 211 – Good Manufacturing Practices for Finished Pharmaceuticals
• WHO TRS 986 Annex 2 – GMP Guidelines for Pharmaceutical Products

9. SOP Version

Version: 2.0

10. Approval Section

11. Annexures

Annexure-1: Material Return Register

Annexure-2: Certificate of Analysis (CoA)

Annexure-3: Return Approval Form

Revision History:

Standard Operating Procedure for Handling Damaged Raw Material Packs in Elixir Manufacturing

1. Purpose

The purpose of this SOP is to establish a standard procedure for identifying, reporting, and managing damaged raw material containers or packs received in the Elixir Department, ensuring product integrity, compliance, and traceability.

2. Scope

This SOP applies to all raw material packs including APIs, excipients, solvents, and additives received at the Elixir Department’s warehouse that are found to be physically damaged, leaking, contaminated, or improperly sealed.

3. Responsibilities

• Warehouse Assistant:
  • Inspect incoming material packs and identify visible damages.
  • Segregate damaged containers and report to the supervisor.
• Warehouse Supervisor:
  • Verify damage, document incident, and initiate disposition process.
• QA Personnel:
  • Assess product integrity and determine if material is usable or needs rejection.
  • Approve final action and maintain deviation or incident report.

4. Accountability

The Warehouse In-Charge is accountable for ensuring that damaged material handling follows this SOP, with oversight from the QA department for decision making and documentation.

5. Procedure

5.1 Inspection at Receipt

1. Upon receiving raw materials, inspect each container for:
   • Tears, punctures, or holes in packaging
   • Leaking or wet outer surfaces
   • Broken seals or tamper evidence
   • Contamination such as dust, insects, or foreign material
2. If any damage is observed, do not move the material into the main storage area.

5.2 Segregation and Identification

1. Move the damaged container to the designated “Damaged Material Hold Area.”
2. Label the container as “Damaged – Under Investigation” (Red Tag) with:
   • Date
   • Material Name
   • Batch Number
   • Received By

5.3 Documentation and Intimation

1. Enter the details of the damaged pack in the Damaged Material Register.
2. Notify the Warehouse Supervisor and QA for joint inspection.
3. Photograph the damage (if possible) for record keeping.

5.4 Assessment by QA

1. QA inspects the material to determine:
   • Extent and type of damage
   • Possibility of contamination or exposure
   • Integrity of primary packaging
2. If the primary pack is intact, QA may recommend use after appropriate labeling and documentation.
3. If the material is deemed unfit, QA will reject the batch and update the inventory status accordingly.

5.5 Disposition and Reporting

1. Rejected material must be moved to the “Rejected Material Area.”
2. Send a notification to the purchase team and vendor if needed.
3. Complete the Deviation/Incident Report (Annexure-3) and attach supporting documents.
4. All actions must be signed and approved by the QA Head.

6. Abbreviations

• QA: Quality Assurance
• SOP: Standard Operating Procedure
• API: Active Pharmaceutical Ingredient

7. Documents

1. Damaged Material Register (Annexure-1)
2. Photographic Record and Inspection Notes (Annexure-2)
3. Deviation/Incident Report (Annexure-3)

8. References

• WHO Technical Report Series 986 – Annex 2: GMP Guidelines
• 21 CFR Part 211 – Current Good Manufacturing Practice

9. SOP Version

Version: 2.0

10. Approval Section

11. Annexures

Annexure-1: Damaged Material Register

Annexure-2: Inspection Notes

Annexure-3: Deviation/Incident Report

Revision History:

Standard Operating Procedure for Segregation of Quarantined and Approved Materials in Elixir Manufacturing

1. Purpose

This SOP outlines the procedure for physical and systemic segregation of quarantined and approved raw materials to avoid cross-contamination, mix-ups, and ensure compliance with GMP regulations within the Elixir Department.

2. Scope

This SOP applies to all raw materials, excipients, solvents, and APIs received in the warehouse of the Elixir Department, covering quarantine, sampling, approval, rejection, and movement controls.

3. Responsibilities

• Warehouse Personnel:
  • Store materials as per their status (Quarantine/Approved/Rejected).
  • Ensure area-wise segregation and accurate labeling.
• QC Department:
  • Sample and analyze materials and assign approval or rejection status.
• QA Department:
  • Verify segregation and maintain records of material status updates.

4. Accountability

The Warehouse In-Charge is accountable for ensuring proper segregation and record maintenance of quarantined and approved materials as per GMP norms.

5. Procedure

5.1 Material Receipt and Initial Quarantine

1. Upon receipt of raw materials, verify the delivery against the purchase order and generate a Goods Receipt Note (GRN).
2. Label each container with a “Quarantine” tag (red color) and transfer it to the designated quarantine area.
3. Record material entry in the inventory management system with “Quarantine” status.

5.2 Sampling and Quality Control

1. QC shall perform sampling as per the sampling SOP using appropriate tools and under controlled conditions.
2. Retain samples, test the material, and generate the Certificate of Analysis (CoA).
3. Based on test results, update material status in the system as either “Approved” (green label) or “Rejected” (yellow label).

5.3 Area Segregation

1. Maintain dedicated areas with physical barriers or designated zones for:
   • Quarantine Materials
   • Approved Materials
   • Rejected Materials
2. Ensure materials from different status categories are never stored together or transferred without authorization.
3. Post signage and access control measures for each area.

5.4 Material Movement and Traceability

1. Allow transfer of “Approved” materials only after QA clearance for dispensing or production use.
2. Update inventory status and movement logs for each container movement.
3. Rejected materials shall be moved to the “Rejected” storage area with documentation and root cause analysis initiated.

5.5 Labeling Guidelines

1. Each container shall carry a status-specific label:
   • Red Label: Quarantine – Under QC Review
   • Green Label: Approved – Released for Use
   • Yellow Label: Rejected – Not to be Used
2. Labels must include material name, batch number, status, date, and authorized signatory.

5.6 Documentation and Record Keeping

1. Maintain all entries in the Material Dispensing Log (Annexure-1) and attach test reports (Annexure-2).
2. Complete Approval and Release Form (Annexure-3) and archive in QA records.

6. Abbreviations

• QC: Quality Control
• QA: Quality Assurance
• GRN: Goods Receipt Note
• SOP: Standard Operating Procedure
• CoA: Certificate of Analysis

7. Documents

1. Material Dispensing Log (Annexure-1)
2. Certificate of Analysis (Annexure-2)
3. Approval and Release Form (Annexure-3)

8. References

• WHO TRS 986 Annex 2 – GMP for Pharmaceutical Products
• 21 CFR Part 211 – Current Good Manufacturing Practice
• EU GMP Guide – Chapter 5: Production

9. SOP Version

Version: 2.0

10. Approval Section

11. Annexures

Annexure-1: Material Dispensing Log

Annexure-2: Certificate of Analysis (CoA)

Annexure-3: Approval and Release Form

Revision History:

Standard Operating Procedure for Calibration of Balances Used in Material Dispensing

1. Purpose

To define a systematic procedure for the calibration of balances used during the dispensing of raw materials and excipients in the Elixir Department. This ensures weighing accuracy, minimizes errors, and maintains compliance with GMP.

2. Scope

This SOP applies to all analytical, precision, and top-loading balances used in the dispensing areas (including laminar airflow cabinets and weighing rooms) of the Elixir Department.

3. Responsibilities

• Dispensing Operator:
  • Perform daily calibration checks before start of operation.
  • Record calibration data and report deviations if any.
• Engineering Department:
  • Conduct periodic preventive maintenance and external calibration.
• QA Department:
  • Verify calibration logs and approve equipment for use.

4. Accountability

The Head of the Elixir Department is accountable for ensuring that all balances are calibrated, documented, and maintained in a validated state as per GMP.

5. Procedure

5.1 Types of Calibration

1. Daily Calibration: Performed by the operator using certified standard weights.
2. Monthly Internal Calibration: Conducted by the Engineering team.
3. Annual External Calibration: Performed by an external authorized calibration agency.

5.2 Daily Calibration Procedure

1. Switch on the balance and allow it to warm up for at least 30 minutes.
2. Ensure the balance is clean, levelled, and placed on a vibration-free surface.
3. Use calibrated standard weights (Class F2 or better) with valid calibration certificates.
4. Perform calibration at two points:
   • Low range (e.g., 10 g)
   • High range (e.g., 500 g or 1000 g depending on balance capacity)
5. Record the observed reading and compare it against the standard weight. Acceptable tolerance: ±0.1% or as specified in the balance SOP.
6. If reading is outside the tolerance limit, report immediately to the Engineering Department and QA.

5.3 Monthly and Annual Calibration

1. Engineering shall perform internal calibration checks and adjust balance if deviation is observed.
2. Annual calibration must be done by a NABL-accredited agency and traceable to national standards.
3. Calibration certificates must be filed and referenced in the equipment qualification record.

5.4 Labeling and Equipment Status

1. All balances must have a calibration status label affixed indicating:
   • Equipment ID
   • Last Calibration Date
   • Next Calibration Due Date
   • Engineer Initials
2. Balances without valid calibration label must not be used and should be tagged “Under Maintenance.”

5.5 Documentation and Deviation Management

1. Enter daily calibration results in the Balance Calibration Log (Annexure-1).
2. Attach calibration certificates in the Equipment Qualification File.
3. Report any deviation or failure to QA using a deviation report form. QA will investigate and approve further action.

6. Abbreviations

• QA: Quality Assurance
• SOP: Standard Operating Procedure
• NABL: National Accreditation Board for Testing and Calibration Laboratories
• GMP: Good Manufacturing Practice

7. Documents

1. Balance Calibration Log (Annexure-1)
2. Calibration Certificate (Annexure-2)
3. Deviation Report Form (Annexure-3)

8. References

• ICH Q7: GMP for Active Pharmaceutical Ingredients
• 21 CFR Part 211 – Current Good Manufacturing Practice
• IS/ISO/IEC 17025 – Calibration and Testing Laboratories

9. SOP Version

Version: 2.0

10. Approval Section

11. Annexures

Annexure-1: Balance Calibration Log

Annexure-2: Calibration Certificate

Annexure-3: Deviation Report Form

Revision History:

Standard Operating Procedure for Using Barcode Systems During Material Dispensing

1. Purpose

This SOP defines the procedure for the use of barcode scanning systems during the dispensing of raw materials and excipients in the Elixir Department to ensure accuracy, traceability, and compliance with Good Manufacturing Practices (GMP).

2. Scope

This SOP applies to all personnel responsible for dispensing raw materials and excipients using barcode scanners for material identification, verification, and tracking during dispensing in the Elixir Department.

3. Responsibilities

• Dispensing Operator:
  • Scan materials using the barcode reader and ensure correct entry into the system.
  • Label all dispensed materials with updated barcoded labels.
• IT/Automation Officer:
  • Ensure the barcode system is functional and backed up regularly.
• Production Supervisor:
  • Verify system logs and ensure proper barcode use during dispensing.
• QA Personnel:
  • Review barcode records and verify accuracy of dispensing entries.

4. Accountability

The Production Head of the Elixir Department is accountable for ensuring the use of barcode systems during dispensing operations as per this SOP, and for maintaining electronic records in compliance with GMP.

5. Procedure

5.1 System Access and Verification

1. Log in to the Material Dispensing System using authorized credentials.
2. Verify the barcode scanner is calibrated and functional before each session.
3. Check that the printer for barcode labels is operational and loaded with proper media.

5.2 Barcode Scanning for Material Identification

1. Scan the barcode on the raw material/excipient container to retrieve:
   • Material Name
   • Batch Number
   • Storage Conditions
   • Approval Status
2. Confirm that the scanned information matches the Batch Manufacturing Record (BMR).
3. Reject the material if there is a mismatch or if the approval status is ‘Quarantine’ or ‘Rejected’.

5.3 Barcode Verification During Dispensing

1. Once the correct material is confirmed, place the container inside the dispensing area or LAF.
2. Dispense the required quantity using calibrated equipment and record the actual dispensed amount in the system.
3. Generate a new barcode label indicating:
   • Material Name
   • Quantity Dispensed
   • Dispensed By
   • Date of Dispensing
   • Batch Number
4. Affix the printed barcode label to the dispensed container.

5.4 System Recording and Printing

1. Ensure that all scanned and printed records are stored in the central database.
2. Print hard copies of dispensing records and attach them to the respective BMR.
3. Any errors in scanning or printing should be reported to the IT department immediately.

5.5 End-of-Process Checks

1. Verify that all dispensed materials have valid, updated barcoded labels.
2. Cross-check physical labels with system logs before transferring materials to production.
3. Review system-generated logs and have them signed by the Production Supervisor and QA Officer.

6. Abbreviations

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

7. Documents

1. Material Dispensing Log (Annexure-1)
2. Certificate of Analysis (Annexure-2)
3. Approval and Release Form (Annexure-3)

8. References

• 21 CFR Part 11 – Electronic Records and Signatures
• WHO GMP Guidelines for Pharmaceutical Production
• EU GMP Annex 11 – Computerised Systems

9. SOP Version

Version: 2.0

10. Approval Section

11. Annexures

Annexure-1: Material Dispensing Log

Annexure-2: Certificate of Analysis (CoA)

Annexure-3: Approval and Release Form

Revision History:

Standard Operating Procedure for Dispensing of Materials Under Laminar Airflow Cabinet

1. Purpose

The purpose of this SOP is to define the standardized procedure for dispensing raw materials and excipients under a laminar airflow (LAF) cabinet to maintain cleanliness, prevent contamination, and ensure compliance with GMP in the Elixir Department.

2. Scope

This SOP applies to all activities related to the dispensing of materials under a laminar airflow cabinet, including setup, operation, cleaning, verification, and documentation, for materials used in elixir manufacturing.

3. Responsibilities

• Dispensing Operator:
  • Perform material dispensing under the LAF as per instructions.
  • Ensure aseptic handling and cleaning before and after dispensing.
• Production Supervisor:
  • Verify cleanliness and suitability of LAF cabinet prior to use.
  • Monitor dispensing activities and ensure adherence to SOP.
• QA Officer:
  • Conduct periodic checks and approve the use of the LAF area.

4. Accountability

The Production Head of the Elixir Department is accountable for implementing this SOP and ensuring that all materials are dispensed under controlled conditions using LAF to maintain product integrity.

5. Procedure

5.1 Pre-Dispensing Setup

1. Ensure the LAF cabinet is validated and has a current certification.
2. Switch on the cabinet blower and UV light 30 minutes prior to dispensing.
3. Clean all internal surfaces using 70% IPA (Isopropyl Alcohol) in “L” pattern wiping.
4. Ensure proper gowning and use of PPE before entering the LAF area.
5. Calibrate and verify weighing balance inside the LAF before use.

5.2 Material Handling and Dispensing

1. Bring only required materials and tools inside the LAF cabinet.
2. Confirm labels, batch numbers, and container integrity before opening.
3. Dispense materials using pre-cleaned scoops and containers.
4. Weigh each material accurately and note the readings in the dispensing log.
5. Close and seal all primary containers immediately after use.

5.3 Post-Dispensing Activities

1. Remove all tools, containers, and materials from the LAF cabinet.
2. Clean all surfaces with 70% IPA and allow to dry naturally.
3. Switch off the blower after 15 minutes of post-cleaning operation.
4. Record LAF usage, cleaning, and operator details in the LAF Usage Logbook.

5.4 Labeling and Documentation

1. Label the dispensed containers with:
   • Material Name
   • Batch Number
   • Quantity Dispensed
   • Date
   • Dispensed By
2. Document all activities in the Material Dispensing Log (Annexure-1).
3. Attach Certificate of Analysis (Annexure-2) and Approval and Release Form (Annexure-3).

6. Abbreviations

• LAF: Laminar Airflow
• IPA: Isopropyl Alcohol
• QA: Quality Assurance
• SOP: Standard Operating Procedure
• CoA: Certificate of Analysis

7. Documents

1. Material Dispensing Log (Annexure-1)
2. Certificate of Analysis (Annexure-2)
3. Approval and Release Form (Annexure-3)

8. References

• WHO TRS 961 – Annex 6: GMP for Sterile Pharmaceutical Products
• EU GMP Annex 1 – Manufacture of Sterile Medicinal Products
• 21 CFR Part 211 – Current Good Manufacturing Practice

9. SOP Version

Version: 2.0

10. Approval Section

11. Annexures

Annexure-1: Material Dispensing Log

Annexure-2: Certificate of Analysis (CoA)

Annexure-3: Approval and Release Form

Revision History: