Standard Operating Procedure for Handling of Spillage During Material Dispensing

1. Purpose

To define the procedure for handling any spillage of raw materials, excipients, or solvents during dispensing operations in the Elixir Department to ensure safety, minimize contamination, and comply with GMP practices.

2. Scope

This SOP is applicable to all personnel involved in dispensing of materials for elixir manufacturing and covers all types of spills (powders, liquids, solvents) within dispensing booths or controlled areas.

3. Responsibilities

• Dispensing Operator:
  • Immediately report and initiate first response for any spill incident.
  • Clean minor spills using approved materials and PPE.
• Supervisor:
  • Assess the spillage, classify the incident (minor/major), and coordinate cleanup.
  • Ensure appropriate documentation is maintained.
• QA Officer:
  • Review and approve the cleanup procedure and determine material usability post-incident.

4. Accountability

The Production Head and Safety Officer are accountable for ensuring adherence to this SOP and implementation of corrective measures after spillage.

5. Procedure

5.1 Classification of Spillage

1. Minor Spillage: Small quantities that do not pose chemical hazards and can be cleaned by dispensing personnel.
2. Major Spillage: Large volume spills, hazardous solvent spillage, or contamination risk requiring immediate supervisor and QA involvement.

5.2 General Precautions

1. Ensure spill kits and PPE (gloves, mask, goggles) are available in the dispensing area.
2. Place warning signage (“Spill Area – Do Not Enter”) around the affected zone.

5.3 Handling Minor Spillage

1. Wear appropriate PPE before initiating cleanup.
2. Collect powder spillage using a HEPA-filtered vacuum or wet lint-free wipes.
3. For liquids/solvents, use absorbent pads or spill pillows to soak the material.
4. Dispose of waste in designated yellow/red biohazard bags and label as “Spill Waste.”
5. Clean the surface with 70% IPA or other approved disinfectant.
6. Document the incident in the Spill Register (Annexure-1).

5.4 Handling Major Spillage

1. Immediately evacuate non-essential personnel and notify the area supervisor and QA.
2. Isolate the area and switch off HVAC if flammable solvents are involved.
3. Use chemical-resistant gloves, goggles, face shield, and respirator (if required).
4. Clean as per validated SOP for hazardous chemical containment.
5. Dispose contaminated items as per waste handling SOP.
6. Fill Deviation Report (Annexure-2) and conduct root cause analysis if repeated.

5.5 Post-Cleanup Verification

1. QA to inspect the area and confirm it is clean and safe for operation.
2. Record the clearance status in the Spill Register and resume dispensing only after QA sign-off.

6. Abbreviations

• SOP: Standard Operating Procedure
• QA: Quality Assurance
• PPE: Personal Protective Equipment
• HEPA: High Efficiency Particulate Air

7. Documents

1. Spill Register (Annexure-1)
2. Deviation Report (Annexure-2)
3. Post-Spillage Clearance Log (Annexure-3)

8. References

• OSHA Guidelines for Chemical Spills
• WHO GMP – Pharmaceutical Production Safety Practices

9. SOP Version

Version: 2.0

10. Approval Section

11. Annexures

Annexure-1: Spill Register

Annexure-2: Deviation Report

Annexure-3: Post-Spillage Clearance Log

Revision History:

Standard Operating Procedure for Recording Dispensed Quantities in Batch Manufacturing Record (BMR)

1. Purpose

To define the procedure for accurately recording dispensed material quantities in the Batch Manufacturing Record (BMR) in the Elixir Department, ensuring traceability, compliance with cGMP, and documentation integrity.

2. Scope

This SOP applies to all materials dispensed for use in elixir formulations including active ingredients, excipients, solvents, and preservatives. It is applicable to production and quality assurance personnel involved in BMR documentation.

3. Responsibilities

• Dispensing Operator:
  • Enter the actual dispensed quantities into the BMR as per batch requirements.
• Supervisor:
  • Verify and countersign the recorded entries for accuracy and completeness.
• QA Officer:
  • Audit the entries and ensure corrections (if any) are performed as per ALCOA+ principles.

4. Accountability

The Production Head is accountable for ensuring that all dispensed quantities are accurately recorded and verified in the BMR in accordance with GMP documentation practices.

5. Procedure

5.1 Before Recording

1. Ensure the correct BMR version is issued and the batch number is clearly mentioned.
2. Cross-check the approved bill of materials and the actual materials dispensed against the Material Requisition Form.

5.2 Entry of Dispensed Quantities

1. Record the following details in the “Material Dispensing Section” of the BMR:
   • Material Name
   • Material Code (if applicable)
   • Batch Number of Material
   • Quantity Required
   • Quantity Dispensed
   • Container Number(s)
   • Date and Time of Dispensing
   • Signature of Dispensing Operator
2. Enter values in legible handwriting using a blue or black permanent pen.
3. Do not overwrite; for corrections, strike a single line, write the correct value, and initial with date/time.

5.3 Review and Verification

1. The Supervisor shall:
   • Verify that the actual quantity matches with batch requirement within allowable limits.
   • Ensure no unauthorized correction or tampering is observed.
   • Sign and date the verification section.
2. QA shall:
   • Randomly check selected entries and ensure they match with the Dispensing Logbook and labels.
   • Initial and date the reviewed pages in the BMR.

5.4 Reconciliation Entry

1. Record the reconciliation at the end of the dispensing table:
   • Total Quantity Required
   • Total Quantity Dispensed
   • Excess/Shortage (if any) with reason
2. Sign and verify the reconciliation data with QA authorization.

6. Abbreviations

• BMR: Batch Manufacturing Record
• QA: Quality Assurance
• GMP: Good Manufacturing Practice
• ALCOA+: Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, and Available

7. Documents

1. Batch Manufacturing Record (Annexure-1)
2. Material Dispensing Log (Annexure-2)
3. Verification and Reconciliation Sheet (Annexure-3)

8. References

• 21 CFR Part 211 – Good Manufacturing Practice for Finished Pharmaceuticals
• WHO TRS 996 Annex 5 – GMP for Documentation

9. SOP Version

Version: 2.0

10. Approval Section

11. Annexures

Annexure-1: Batch Manufacturing Record – Material Entry Section

Annexure-2: Material Dispensing Log

Annexure-3: Verification and Reconciliation Sheet

Revision History:

Standard Operating Procedure for Use of Material Transfer Hatches in Elixir Manufacturing

1. Purpose

This SOP defines the procedure for the proper use and maintenance of material transfer hatches between different classified areas in the Elixir Department to ensure controlled material movement and prevent cross-contamination.

2. Scope

This SOP applies to the use of dynamic and static pass boxes (material hatches) for transferring raw materials, packaging materials, and finished goods between warehouse, dispensing, and manufacturing areas in the Elixir Department.

3. Responsibilities

• Dispensing Operator:
  • Ensure materials are placed and removed as per sequence.
  • Clean and disinfect the hatch before and after use.
• Area Supervisor:
  • Monitor material movement and verify entries in the transfer logbook.
• QA Officer:
  • Perform periodic checks and ensure compliance with hatch usage protocols.

4. Accountability

The Engineering Head and Production Head are accountable for ensuring the proper functioning, maintenance, and use of transfer hatches in accordance with GMP standards.

5. Procedure

5.1 Hatch Description and Types

1. Static Pass Box: Non-ventilated enclosure used between non-critical areas (e.g., warehouse to corridor).
2. Dynamic Pass Box: Equipped with HEPA-filtered air for controlled transfer between clean areas (e.g., dispensing to manufacturing).

5.2 Pre-Use Checks

1. Ensure both doors are closed and interlock is functional.
2. Inspect the inner chamber for cleanliness and switch on UV light (if applicable) for 15 minutes before first use.
3. Record cleaning and UV light activation in the Material Transfer Hatch Logbook (Annexure-1).

5.3 Material Loading

1. Open the non-classified side door, place the material inside the hatch on a clean surface.
2. Close the door fully and ensure interlock is engaged before opening the classified area door.
3. Record material name, batch number, source, and destination in the hatch logbook.

5.4 Material Receiving

1. Personnel from the classified side shall open the door only after confirming the outer door is locked.
2. Remove the material, verify the label, and disinfect with 70% IPA before transferring to the next process area.

5.5 Post-Use Sanitization

1. After each use, clean the inner surface with lint-free wipes soaked in 70% IPA.
2. Switch on UV light (if provided) for 15 minutes between cycles.
3. Record sanitization time and initials in the hatch logbook.

5.6 Maintenance and Calibration

1. Engineering department shall:
   • Perform quarterly preventive maintenance.
   • Verify interlocking mechanism, HEPA filter status, and UV lamp efficacy (Annexure-2).

6. Abbreviations

• IPA: Isopropyl Alcohol
• SOP: Standard Operating Procedure
• GMP: Good Manufacturing Practice
• HEPA: High-Efficiency Particulate Air

7. Documents

1. Material Transfer Hatch Logbook (Annexure-1)
2. Quarterly Hatch Maintenance Record (Annexure-2)
3. Hatch Cleaning Checklist (Annexure-3)

8. References

• WHO TRS 961 Annex 6 – GMP for HVAC Systems
• EU GMP – Volume 4, Annex 1: Manufacture of Sterile Products

9. SOP Version

Version: 2.0

10. Approval Section

11. Annexures

Annexure-1: Material Transfer Hatch Logbook

Annexure-2: Quarterly Hatch Maintenance Record

Annexure-3: Hatch Cleaning Checklist

Revision History:

Standard Operating Procedure for Label Generation and Application During Material Dispensing

1. Purpose

This SOP outlines the procedure for generation, printing, verification, and application of labels during the dispensing of materials in the Elixir Department, ensuring proper identification, traceability, and regulatory compliance.

2. Scope

This SOP applies to all raw materials, excipients, solvents, and active ingredients dispensed for elixir manufacturing. It covers computer-generated label creation, manual backup procedures, and affixing processes.

3. Responsibilities

• Dispensing Operator:
  • Generate and print correct labels after dispensing activity.
  • Affix labels neatly and legibly to all dispensed containers.
• Supervisor:
  • Verify label content for correctness before release.
• QA Personnel:
  • Audit label format and details for accuracy and compliance.

4. Accountability

The Production Head is accountable for implementation of this SOP and ensuring labels are generated and applied correctly to avoid mix-ups and ensure traceability.

5. Procedure

5.1 Label Format

1. All dispensing labels must contain the following:
   • Material Name
   • Material Code (if applicable)
   • Batch Number
   • Quantity Dispensed
   • Dispensed Date
   • Container Number (e.g., 1 of 3)
   • Dispensed By / Verified By
   • Status (e.g., Approved, Quarantine, Rejected)
2. The label size and font must be readable from a minimum distance of 1 meter.

5.2 Label Generation

1. Log into the Label Management System using individual credentials.
2. Select the correct template based on the material type (API, excipient, solvent, etc.).
3. Enter batch number, quantity, and container details as per BMR/MRF.
4. Print labels using a barcode-enabled label printer. Retain one copy in the batch record file.

5.3 Manual Labeling (Backup)

1. In case of system failure, use pre-approved label templates available in the dispensing area.
2. Fill in details legibly using a permanent marker. QA shall verify and sign the handwritten label.
3. Replace with system-generated labels once system is restored.

5.4 Label Application

1. Affix the label on the front face of the container, avoiding folded or obscured placement.
2. Ensure labels are:
   • Clean
   • Straight
   • Intact (not torn or peeling)
3. Do not reuse damaged or used labels.

5.5 Label Verification

1. Before transferring dispensed materials, the supervisor must verify the following:
   • Label matches BMR and Dispensing Log
   • Correct container number and total quantity
   • Legibility and accuracy of text and barcode
2. QA shall verify a sample of the printed labels during batch release audit.

6. Abbreviations

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

7. Documents

1. Label Logbook (Annexure-1)
2. Printed Label Template (Annexure-2)
3. Label Verification Checklist (Annexure-3)

8. References

• 21 CFR Part 211 – GMP for Finished Pharmaceuticals
• EU GMP – Chapter 4: Documentation
• WHO GMP Guidelines – Labeling Requirements

9. SOP Version

Version: 2.0

10. Approval Section

11. Annexures

Annexure-1: Label Logbook

Annexure-2: Printed Label Template

Annexure-3: Label Verification Checklist

Revision History:

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: