Standard Operating Procedure for Verifying Storage Conditions Prior to Raw Material Issuance

1. Purpose

This Standard Operating Procedure (SOP) outlines the procedures to verify that raw materials are stored under appropriate conditions before being issued for production. This ensures material integrity, quality, and compliance with Good Manufacturing Practices (GMP).

2. Scope

This SOP applies to all raw materials, including Active Pharmaceutical Ingredients (APIs), excipients, solvents, and other chemicals stored in the warehouse, which are to be issued for production or quality control.

3. Responsibilities

• Warehouse Personnel: Responsible for checking and documenting storage conditions before raw materials are issued.
• Warehouse Manager: Supervise storage condition verification and ensure compliance with procedures.
• Quality Assurance (QA): Approve issuance after verifying that materials meet storage condition requirements.

4. Accountability

The Warehouse Manager is accountable for ensuring that all raw materials are stored and issued under appropriate conditions. The QA Manager is responsible for verifying compliance with GMP standards.

5. Procedure

5.1 Verification of Storage Conditions

1. Review of Temperature and Humidity Logs:
   • Verify that raw materials have been stored within the specified temperature and humidity ranges as per product requirements.
   • Review automated monitoring systems or manual logs to confirm compliance.
   • Document findings in the Storage Condition Verification Log (Annexure-1).
2. Physical Inspection of Storage Areas:
   • Inspect the storage area to ensure cleanliness, absence of contamination, and compliance with segregation policies.
   • Check for signs of leaks, pest infestation, or other environmental risks.
   • Record observations in the Storage Area Inspection Log (Annexure-2).

5.2 Inspection of Raw Material Packaging

1. Container Integrity Check:
   • Inspect raw material containers for signs of damage, leakage, or tampering.
   • Ensure that labels are intact, legible, and include batch numbers, expiry dates, and storage conditions.
   • Document container inspection results in the Packaging Inspection Log (Annexure-3).
2. Verification of Expiry Dates:
   • Ensure that materials being issued are within their expiry dates.
   • Cross-verify expiry dates with inventory records and batch documentation.
   • Record expiry verification in the Expiry Date Verification Log (Annexure-4).

5.3 Authorization for Issuance

1. Preparation of Issuance Request:
   • Warehouse personnel must prepare an issuance request after verifying storage conditions.
   • The request should include batch numbers, quantity required, and storage verification details.
   • Document the request in the Material Issuance Request Log (Annexure-5).
2. QA Approval for Issuance:
   • QA must review the storage condition verification and approve the issuance of materials.
   • Approval should be recorded in the QA Approval Log (Annexure-6).

5.4 Handling Deviations in Storage Conditions

1. Identification and Reporting of Deviations:
   • Identify any deviations from specified storage conditions, such as temperature excursions, damaged packaging, or expired materials.
   • Report deviations immediately to the Warehouse Manager and QA.
   • Document deviations in the Deviation Log (Annexure-7).
2. Corrective Actions and Quarantine Procedures:
   • Quarantine materials that do not meet storage conditions until further evaluation.
   • Implement corrective actions based on QA recommendations and document in the Corrective Action Log (Annexure-8).

5.5 Final Issuance and Documentation

1. Final Verification and Issuance:
   • Perform a final verification before physically issuing the raw materials to the production or laboratory area.
   • Ensure materials are transported under appropriate conditions and recorded in the Final Issuance Log (Annexure-9).
2. Record Retention:
   • Maintain all records related to storage condition verification and material issuance for a minimum of five years.
   • Document record retention details in the Record Retention Log (Annexure-10).

6. Abbreviations

• SOP: Standard Operating Procedure
• GMP: Good Manufacturing Practice
• QA: Quality Assurance
• ERP: Enterprise Resource Planning

7. Documents

1. Storage Condition Verification Log (Annexure-1)
2. Storage Area Inspection Log (Annexure-2)
3. Packaging Inspection Log (Annexure-3)
4. Expiry Date Verification Log (Annexure-4)
5. Material Issuance Request Log (Annexure-5)
6. QA Approval Log (Annexure-6)
7. Deviation Log (Annexure-7)
8. Corrective Action Log (Annexure-8)
9. Final Issuance Log (Annexure-9)
10. Record Retention Log (Annexure-10)

8. References

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

9. SOP Version

Version: 2.0

10. Approval Section

11. Annexures

Annexure-1: Storage Condition Verification Log

Annexure-2: Storage Area Inspection Log

Annexure-3: Packaging Inspection Log

Annexure-4: Expiry Date Verification Log

Annexure-5: Material Issuance Request Log

Annexure-6: QA Approval Log

Annexure-7: Deviation Log

Annexure-8: Corrective Action Log

Annexure-9: Final Issuance Log

Annexure-10: Record Retention Log

Revision History:

Standard Operating Procedure for Controlled Storage of Radioactive or Hazardous Raw Materials

1. Purpose

This Standard Operating Procedure (SOP) establishes guidelines for the safe and compliant storage of radioactive and hazardous raw materials. It ensures the protection of personnel, property, and the environment while maintaining compliance with regulatory requirements.

2. Scope

This SOP applies to all radioactive and hazardous raw materials received, stored, and handled within the warehouse facilities. It covers materials classified as flammable, corrosive, toxic, carcinogenic, reactive, or radioactive.

3. Responsibilities

• Warehouse Personnel: Ensure proper storage, labeling, and handling of hazardous and radioactive materials.
• Warehouse Manager: Supervise the controlled storage process and ensure compliance with safety and regulatory guidelines.
• Quality Assurance (QA): Verify compliance with Good Manufacturing Practices (GMP) and ensure proper documentation of storage conditions.
• Safety Officer: Ensure safety procedures are followed and proper Personal Protective Equipment (PPE) is used during handling and storage.
• Radiation Safety Officer (RSO): Oversee the storage and handling of radioactive materials and ensure compliance with radiation protection regulations.

4. Accountability

The Warehouse Manager is accountable for ensuring hazardous and radioactive materials are stored safely and in compliance with regulatory guidelines. The QA Manager and Radiation Safety Officer are responsible for verifying adherence to safety protocols and proper documentation.

5. Procedure

5.1 Receiving and Inspection of Hazardous and Radioactive Materials

1. Initial Inspection:
   • Inspect all incoming hazardous and radioactive materials for leaks, damage, or improper labeling.
   • Ensure that containers are intact, sealed, and labeled with the appropriate hazard symbols and handling instructions.
   • Verify accompanying documentation, such as the Certificate of Analysis (COA), Material Safety Data Sheet (MSDS), and radiation transport certificates, if applicable.
   • Document receipt and inspection in the Hazardous Material Receiving Log (Annexure-1).
2. Verification of Documentation:
   • Ensure all regulatory documents are in place before accepting materials into storage.
   • Record verification in the Documentation Verification Log (Annexure-2).

5.2 Storage Conditions for Hazardous and Radioactive Materials

1. Controlled Access Areas:
   • Store hazardous and radioactive materials in restricted-access areas with controlled entry, monitored by keycards or biometric access systems.
   • Document access permissions in the Access Control Log (Annexure-3).
2. Storage Environment:
   • Store materials in well-ventilated, temperature-controlled environments, ensuring segregation based on material compatibility (e.g., flammable materials separate from oxidizers).
   • For radioactive materials, use lead-shielded storage containers or cabinets, with regular radiation monitoring in place.
   • Document storage conditions in the Storage Condition Log (Annexure-4).

5.3 Labeling and Segregation of Hazardous and Radioactive Materials

1. Proper Labeling:
   • Ensure all hazardous and radioactive materials are labeled with hazard symbols, batch numbers, expiry dates, and storage conditions.
   • Radioactive materials should be marked with the trefoil radiation symbol and the words “Caution – Radioactive Material.”
   • Record labeling activities in the Labeling Log (Annexure-5).
2. Segregation Protocols:
   • Segregate incompatible materials, such as acids from bases and flammable materials from oxidizers.
   • Ensure radioactive materials are stored separately from non-radioactive materials, with adequate shielding and signage.
   • Document segregation protocols in the Segregation Log (Annexure-6).

5.4 Radiation Safety and Monitoring

1. Radiation Monitoring Procedures:
   • Regularly monitor radiation levels in storage areas using calibrated Geiger counters or dosimeters.
   • Ensure that radiation exposure levels do not exceed permissible limits as defined by regulatory authorities.
   • Document monitoring results in the Radiation Monitoring Log (Annexure-7).
2. Personnel Safety Measures:
   • Ensure personnel handling radioactive materials wear dosimeters and appropriate PPE.
   • Rotate staff handling radioactive materials to minimize exposure time.
   • Document PPE usage and monitoring in the Personnel Safety Log (Annexure-8).

5.5 Spill and Emergency Response Procedures

1. Spill Prevention:
   • Ensure all containers are securely closed and stored in spill-containment trays or cabinets.
   • Inspect storage areas regularly for signs of leaks or spills.
   • Document inspections in the Spill Prevention Log (Annexure-9).
2. Emergency Spill Response:
   • In the event of a spill, immediately evacuate the area, contain the spill if safe to do so, and notify the Safety Officer and RSO.
   • Use appropriate spill kits and follow emergency response protocols outlined in the MSDS or radiation safety manual.
   • Document spill incidents and corrective actions in the Spill Incident Log (Annexure-10).

6. Abbreviations

• SOP: Standard Operating Procedure
• GMP: Good Manufacturing Practice
• QA: Quality Assurance
• PPE: Personal Protective Equipment
• RSO: Radiation Safety Officer
• MSDS: Material Safety Data Sheet

7. Documents

1. Hazardous Material Receiving Log (Annexure-1)
2. Documentation Verification Log (Annexure-2)
3. Access Control Log (Annexure-3)
4. Storage Condition Log (Annexure-4)
5. Labeling Log (Annexure-5)
6. Segregation Log (Annexure-6)
7. Radiation Monitoring Log (Annexure-7)
8. Personnel Safety Log (Annexure-8)
9. Spill Prevention Log (Annexure-9)
10. Spill Incident Log (Annexure-10)

8. References

• 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals
• WHO GMP Guidelines
• International Atomic Energy Agency (IAEA) Radiation Safety Standards
• OSHA Hazardous Materials Handling Standards

9. SOP Version

Version: 2.0

10. Approval Section

11. Annexures

Annexure-1: Hazardous Material Receiving Log

Annexure-2: Documentation Verification Log

Annexure-3: Access Control Log

Annexure-4: Storage Condition Log

Annexure-5: Labeling Log

Annexure-6: Segregation Log

Annexure-7: Radiation Monitoring Log

Annexure-8: Personnel Safety Log

Annexure-9: Spill Prevention Log

Annexure-10: Spill Incident Log

Revision History:

Standard Operating Procedure for Handling and Storage of Liquid Raw Materials in Bulk Containers

1. Purpose

This Standard Operating Procedure (SOP) outlines the guidelines for the safe handling and storage of liquid raw materials in bulk containers, ensuring product integrity, safety, and compliance with Good Manufacturing Practices (GMP).

2. Scope

This SOP applies to all liquid raw materials received, handled, and stored in bulk containers, including solvents, oils, and chemicals, within the warehouse facility.

3. Responsibilities

• Warehouse Personnel: Responsible for the safe receipt, handling, and storage of bulk liquid raw materials according to this SOP.
• Warehouse Manager: Supervise handling and storage procedures and ensure compliance with safety and GMP guidelines.
• Quality Assurance (QA): Verify that materials are handled and stored properly and that records are maintained accurately.
• Safety Officer: Ensure that handling procedures meet safety standards and that appropriate personal protective equipment (PPE) is used.

4. Accountability

The Warehouse Manager is accountable for the correct handling and storage of liquid raw materials in bulk containers. The QA Manager is responsible for verifying compliance with GMP and safety regulations.

5. Procedure

5.1 Receiving and Inspection of Bulk Liquid Raw Materials

1. Inspection at Receipt:
   • Inspect bulk containers for visible signs of damage, leaks, or contamination upon arrival.
   • Verify container integrity, including seals, valves, and labeling.
   • Cross-check material documentation (Certificate of Analysis, Material Safety Data Sheet) with the purchase order.
   • Document receipt and inspection in the Bulk Liquid Receiving Log (Annexure-1).
2. Verification of Documentation:
   • Ensure that all required documentation, including batch numbers and expiry dates, is accurate and complete.
   • Record document verification in the Documentation Verification Log (Annexure-2).

5.2 Handling Procedures for Bulk Liquid Raw Materials

1. Use of Handling Equipment:
   • Use forklifts, drum handlers, or pallet jacks for moving heavy bulk containers.
   • Ensure equipment is in good working condition and regularly maintained.
   • Document equipment usage in the Handling Equipment Log (Annexure-3).
2. Manual Handling:
   • When manual handling is necessary, ensure at least two trained personnel are involved.
   • Use proper lifting techniques and PPE, including gloves, safety goggles, and protective clothing.
   • Document manual handling activities in the Manual Handling Log (Annexure-4).

5.3 Storage of Bulk Liquid Raw Materials

1. Storage Conditions:
   • Store bulk containers upright on pallets to prevent leaks and ensure stability.
   • Ensure storage areas are well-ventilated and free from direct sunlight and heat sources.
   • Document storage conditions in the Storage Condition Log (Annexure-5).
2. Segregation and Labeling:
   • Segregate materials based on their chemical nature (flammable, corrosive, etc.) and store in designated areas.
   • Ensure all containers are properly labeled with material name, batch number, expiry date, and hazard warnings.
   • Record segregation and labeling in the Segregation and Labeling Log (Annexure-6).

5.4 Spill Prevention and Emergency Procedures

1. Spill Prevention Measures:
   • Inspect storage areas regularly for signs of leaks or spills.
   • Ensure spill containment kits are available and easily accessible in storage areas.
   • Document spill prevention inspections in the Spill Prevention Log (Annexure-7).
2. Emergency Spill Response:
   • In the event of a spill, immediately contain the spill using appropriate absorbent materials and notify the Safety Officer.
   • Follow emergency response protocols as outlined in the Material Safety Data Sheet (MSDS).
   • Document spill incidents and responses in the Spill Incident Log (Annexure-8).

5.5 Handling Deviations and Corrective Actions

1. Reporting Deviations:
   • Report any deviations, such as improper storage conditions or handling errors, to the Warehouse Manager and QA.
   • Document deviations in the Deviation Log (Annexure-9).
2. Corrective Actions:
   • Investigate the cause of deviations and implement corrective measures, such as retraining personnel or updating procedures.
   • Document corrective actions in the Corrective Action Log (Annexure-10).

6. Abbreviations

• SOP: Standard Operating Procedure
• GMP: Good Manufacturing Practice
• QA: Quality Assurance
• PPE: Personal Protective Equipment
• MSDS: Material Safety Data Sheet

7. Documents

1. Bulk Liquid Receiving Log (Annexure-1)
2. Documentation Verification Log (Annexure-2)
3. Handling Equipment Log (Annexure-3)
4. Manual Handling Log (Annexure-4)
5. Storage Condition Log (Annexure-5)
6. Segregation and Labeling Log (Annexure-6)
7. Spill Prevention Log (Annexure-7)
8. Spill Incident Log (Annexure-8)
9. Deviation Log (Annexure-9)
10. Corrective Action Log (Annexure-10)

8. References

• 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals
• WHO GMP Guidelines
• OSHA Hazardous Materials Handling Standards

9. SOP Version

Version: 2.0

10. Approval Section

11. Annexures

Annexure-1: Bulk Liquid Receiving Log

Annexure-2: Documentation Verification Log

Annexure-3: Handling Equipment Log

Annexure-4: Manual Handling Log

Annexure-5: Storage Condition Log

Annexure-6: Segregation and Labeling Log

Annexure-7: Spill Prevention Log

Annexure-8: Spill Incident Log

Annexure-9: Deviation Log

Annexure-10: Corrective Action Log

Revision History:

Standard Operating Procedure for Periodic Reorganization and Optimization of Warehouse Space

1. Purpose

This Standard Operating Procedure (SOP) outlines the guidelines for the periodic reorganization and optimization of warehouse space to ensure efficient storage, ease of access, and compliance with Good Manufacturing Practices (GMP).

2. Scope

This SOP applies to all raw materials, finished goods, and equipment stored in the warehouse, including Active Pharmaceutical Ingredients (APIs), excipients, solvents, and other chemicals.

3. Responsibilities

• Warehouse Personnel: Assist in the reorganization of warehouse space and ensure proper placement of materials according to the updated plan.
• Warehouse Manager: Oversee the reorganization process, coordinate with other departments, and ensure compliance with storage guidelines.
• Quality Assurance (QA): Verify that the reorganization complies with GMP standards and ensure proper documentation.
• Health & Safety Officer: Ensure that the reorganization plan adheres to safety regulations and minimize risks during the process.

4. Accountability

The Warehouse Manager is accountable for ensuring that the warehouse space is reorganized effectively and efficiently. The QA Manager is responsible for ensuring compliance with regulatory standards and verifying the reorganization process.

5. Procedure

5.1 Planning the Reorganization

1. Assessment of Current Warehouse Layout:
   • Conduct a thorough assessment of the current warehouse layout, identifying areas of inefficiency or congestion.
   • Evaluate storage conditions such as temperature, humidity, and accessibility.
   • Document the assessment in the Warehouse Assessment Log (Annexure-1).
2. Development of Reorganization Plan:
   • Develop a reorganization plan that optimizes the use of space while ensuring easy access to frequently used materials.
   • Ensure segregation of materials based on their classification (e.g., hazardous, temperature-sensitive, etc.).
   • Document the plan in the Reorganization Plan Log (Annexure-2).

5.2 Implementation of Reorganization

1. Preparation for Reorganization:
   • Inform all warehouse personnel about the reorganization schedule and assign specific roles and responsibilities.
   • Ensure the availability of necessary equipment such as forklifts, trolleys, and labeling tools.
   • Document the preparation details in the Reorganization Preparation Log (Annexure-3).
2. Execution of Reorganization:
   • Begin by moving non-essential or excess materials to temporary holding areas.
   • Relocate materials according to the updated layout plan, ensuring proper labeling and segregation.
   • Ensure that materials are placed on pallets or shelves to prevent direct contact with the floor.
   • Document the execution process in the Reorganization Execution Log (Annexure-4).

5.3 Verification and Documentation

1. QA Verification:
   • QA personnel must verify that the reorganization complies with GMP guidelines and that all materials are properly labeled and stored.
   • Document QA verification in the QA Verification Log (Annexure-5).
2. Updating ERP and Inventory Systems:
   • Update the ERP or inventory management system to reflect new storage locations.
   • Ensure that all documentation related to the reorganization is archived for future reference.
   • Document ERP updates in the Inventory Update Log (Annexure-6).

5.4 Handling Deviations and Corrective Actions

1. Reporting Deviations:
   • Report any deviations, such as incorrect placement of materials or failure to follow the reorganization plan, to the Warehouse Manager and QA.
   • Document deviations in the Deviation Log (Annexure-7).
2. Corrective Actions:
   • Investigate the cause of deviations and implement corrective measures, such as retraining staff or adjusting the reorganization plan.
   • Document corrective actions in the Corrective Action Log (Annexure-8).

6. Abbreviations

• SOP: Standard Operating Procedure
• GMP: Good Manufacturing Practice
• QA: Quality Assurance
• ERP: Enterprise Resource Planning

7. Documents

1. Warehouse Assessment Log (Annexure-1)
2. Reorganization Plan Log (Annexure-2)
3. Reorganization Preparation Log (Annexure-3)
4. Reorganization Execution Log (Annexure-4)
5. QA Verification Log (Annexure-5)
6. Inventory Update Log (Annexure-6)
7. Deviation Log (Annexure-7)
8. Corrective Action Log (Annexure-8)

8. References

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

9. SOP Version

Version: 2.0

10. Approval Section

11. Annexures

Annexure-1: Warehouse Assessment Log

Annexure-2: Reorganization Plan Log

Annexure-3: Reorganization Preparation Log

Annexure-4: Reorganization Execution Log

Annexure-5: QA Verification Log

Annexure-6: Inventory Update Log

Annexure-7: Deviation Log

Annexure-8: Corrective Action Log

Revision History:

Standard Operating Procedure for Identification and Removal of Expired Raw Materials from Storage

1. Purpose

This Standard Operating Procedure (SOP) defines the process for identifying and removing expired raw materials from storage areas to ensure product quality, regulatory compliance, and to prevent the use of non-conforming materials in manufacturing processes.

2. Scope

This SOP applies to all raw materials stored in the warehouse, including Active Pharmaceutical Ingredients (APIs), excipients, solvents, and other chemicals that have a defined shelf life.

3. Responsibilities

• Warehouse Personnel: Perform regular checks of raw materials, identify expired items, and segregate them from usable stock.
• Warehouse Manager: Supervise the identification and removal process and ensure timely updates in the inventory system.
• Quality Assurance (QA): Verify the removal of expired materials and ensure proper documentation and regulatory compliance.

4. Accountability

The Warehouse Manager is accountable for ensuring expired materials are identified and removed in a timely manner. The QA Manager is responsible for verifying compliance with regulatory standards and proper documentation.

5. Procedure

5.1 Identification of Expired Raw Materials

1. Review of Expiry Dates:
   • Warehouse personnel must review the expiry dates of raw materials during routine inventory checks, following First-Expired-First-Out (FEFO) principles.
   • Identify materials that have reached or are nearing their expiry date.
   • Document identified expired materials in the Expired Material Identification Log (Annexure-1).
2. Use of ERP Systems:
   • Use the Enterprise Resource Planning (ERP) or inventory management system to generate reports of materials approaching expiry.
   • Cross-check ERP data with physical inventory to ensure accuracy.
   • Record ERP verification results in the ERP Expiry Report Log (Annexure-2).

5.2 Segregation and Labeling of Expired Materials

1. Segregation Procedures:
   • Immediately segregate expired materials from active inventory and move them to a designated quarantine area for expired materials.
   • Ensure physical barriers or separate storage racks are used to prevent accidental use of expired materials.
   • Document segregation in the Expired Material Segregation Log (Annexure-3).
2. Labeling Requirements:
   • Clearly label expired materials with “EXPIRED” tags, including the material name, batch number, and date of expiry.
   • Ensure labels are prominently visible and comply with GMP labeling standards.
   • Record labeling details in the Expired Material Labeling Log (Annexure-4).

5.3 Removal and Disposal of Expired Materials

1. Approval for Disposal:
   • Submit the list of expired materials to the QA department for approval before disposal.
   • QA must verify the materials and sign off on the disposal request.
   • Document approval in the Disposal Approval Log (Annexure-5).
2. Disposal Procedures:
   • Dispose of expired materials in accordance with environmental regulations and company policies.
   • For hazardous materials, follow specific disposal procedures outlined in the Material Safety Data Sheet (MSDS).
   • Document disposal activities in the Expired Material Disposal Log (Annexure-6).

5.4 Updating Inventory and Documentation

1. Inventory System Updates:
   • Update the ERP or inventory management system to reflect the removal of expired materials from stock.
   • Ensure all related documentation is attached in the ERP system for audit purposes.
   • Record inventory updates in the Inventory Update Log (Annexure-7).
2. Record Retention:
   • Maintain all records related to expired materials for a minimum of five years or as required by regulatory authorities.
   • Ensure records are easily accessible for audits and inspections.
   • Document record retention details in the Record Retention Log (Annexure-8).

5.5 Handling Deviations and Corrective Actions

1. Reporting Deviations:
   • Report any deviations, such as the use of expired materials or failure to remove expired stock, to the Warehouse Manager and QA.
   • Document deviations in the Deviation Log (Annexure-9).
2. Corrective Actions:
   • Investigate the root cause of deviations and implement corrective measures, such as retraining staff or improving tracking systems.
   • Document corrective actions in the Corrective Action Log (Annexure-10).

6. Abbreviations

• SOP: Standard Operating Procedure
• GMP: Good Manufacturing Practice
• QA: Quality Assurance
• ERP: Enterprise Resource Planning
• MSDS: Material Safety Data Sheet

7. Documents

1. Expired Material Identification Log (Annexure-1)
2. ERP Expiry Report Log (Annexure-2)
3. Expired Material Segregation Log (Annexure-3)
4. Expired Material Labeling Log (Annexure-4)
5. Disposal Approval Log (Annexure-5)
6. Expired Material Disposal Log (Annexure-6)
7. Inventory Update Log (Annexure-7)
8. Record Retention Log (Annexure-8)
9. Deviation Log (Annexure-9)
10. Corrective Action Log (Annexure-10)

8. References

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

9. SOP Version

Version: 2.0

10. Approval Section

11. Annexures

Annexure-1: Expired Material Identification Log

Annexure-2: ERP Expiry Report Log

Annexure-3: Expired Material Segregation Log

Annexure-4: Expired Material Labeling Log

Annexure-5: Disposal Approval Log

Annexure-6: Expired Material Disposal Log

Annexure-7: Inventory Update Log

Annexure-8: Record Retention Log

Annexure-9: Deviation Log

Annexure-10: Corrective Action Log

Revision History:

Standard Operating Procedure for Identification and Removal of Expired Raw Materials from Storage

1. Purpose

This Standard Operating Procedure (SOP) defines the process for identifying and removing expired raw materials from storage areas to ensure product quality, regulatory compliance, and to prevent the use of non-conforming materials in manufacturing processes.

2. Scope

This SOP applies to all raw materials stored in the warehouse, including Active Pharmaceutical Ingredients (APIs), excipients, solvents, and other chemicals that have a defined shelf life.

3. Responsibilities

• Warehouse Personnel: Perform regular checks of raw materials, identify expired items, and segregate them from usable stock.
• Warehouse Manager: Supervise the identification and removal process and ensure timely updates in the inventory system.
• Quality Assurance (QA): Verify the removal of expired materials and ensure proper documentation and regulatory compliance.

4. Accountability

The Warehouse Manager is accountable for ensuring expired materials are identified and removed in a timely manner. The QA Manager is responsible for verifying compliance with regulatory standards and proper documentation.

5. Procedure

5.1 Identification of Expired Raw Materials

1. Review of Expiry Dates:
   • Warehouse personnel must review the expiry dates of raw materials during routine inventory checks, following First-Expired-First-Out (FEFO) principles.
   • Identify materials that have reached or are nearing their expiry date.
   • Document identified expired materials in the Expired Material Identification Log (Annexure-1).
2. Use of ERP Systems:
   • Use the Enterprise Resource Planning (ERP) or inventory management system to generate reports of materials approaching expiry.
   • Cross-check ERP data with physical inventory to ensure accuracy.
   • Record ERP verification results in the ERP Expiry Report Log (Annexure-2).

5.2 Segregation and Labeling of Expired Materials

1. Segregation Procedures:
   • Immediately segregate expired materials from active inventory and move them to a designated quarantine area for expired materials.
   • Ensure physical barriers or separate storage racks are used to prevent accidental use of expired materials.
   • Document segregation in the Expired Material Segregation Log (Annexure-3).
2. Labeling Requirements:
   • Clearly label expired materials with “EXPIRED” tags, including the material name, batch number, and date of expiry.
   • Ensure labels are prominently visible and comply with GMP labeling standards.
   • Record labeling details in the Expired Material Labeling Log (Annexure-4).

5.3 Removal and Disposal of Expired Materials

1. Approval for Disposal:
   • Submit the list of expired materials to the QA department for approval before disposal.
   • QA must verify the materials and sign off on the disposal request.
   • Document approval in the Disposal Approval Log (Annexure-5).
2. Disposal Procedures:
   • Dispose of expired materials in accordance with environmental regulations and company policies.
   • For hazardous materials, follow specific disposal procedures outlined in the Material Safety Data Sheet (MSDS).
   • Document disposal activities in the Expired Material Disposal Log (Annexure-6).

5.4 Updating Inventory and Documentation

1. Inventory System Updates:
   • Update the ERP or inventory management system to reflect the removal of expired materials from stock.
   • Ensure all related documentation is attached in the ERP system for audit purposes.
   • Record inventory updates in the Inventory Update Log (Annexure-7).
2. Record Retention:
   • Maintain all records related to expired materials for a minimum of five years or as required by regulatory authorities.
   • Ensure records are easily accessible for audits and inspections.
   • Document record retention details in the Record Retention Log (Annexure-8).

5.5 Handling Deviations and Corrective Actions

1. Reporting Deviations:
   • Report any deviations, such as the use of expired materials or failure to remove expired stock, to the Warehouse Manager and QA.
   • Document deviations in the Deviation Log (Annexure-9).
2. Corrective Actions:
   • Investigate the root cause of deviations and implement corrective measures, such as retraining staff or improving tracking systems.
   • Document corrective actions in the Corrective Action Log (Annexure-10).

6. Abbreviations

• SOP: Standard Operating Procedure
• GMP: Good Manufacturing Practice
• QA: Quality Assurance
• ERP: Enterprise Resource Planning
• MSDS: Material Safety Data Sheet

7. Documents

1. Expired Material Identification Log (Annexure-1)
2. ERP Expiry Report Log (Annexure-2)

8. References

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

9. SOP Version

Version: 2.0

10. Approval Section

11. Annexures

Annexure-1: Expired Material Identification Log

Annexure-2: ERP Expiry Report Log

Revision History:

Standard Operating Procedure for Updating Storage Locations in ERP or Inventory Systems

1. Purpose

This Standard Operating Procedure (SOP) outlines the process for updating and maintaining accurate storage location records in Enterprise Resource Planning (ERP) or inventory management systems to ensure efficient material tracking, prevent discrepancies, and maintain compliance with Good Manufacturing Practices (GMP).

2. Scope

This SOP applies to all warehouse personnel and IT staff involved in the receiving, storing, and managing of raw materials using ERP or inventory management systems.

3. Responsibilities

• Warehouse Personnel: Accurately record storage locations in ERP systems upon receiving and relocating materials.
• Warehouse Manager: Review and verify storage location updates regularly and ensure data accuracy.
• IT Personnel: Maintain the ERP system, troubleshoot issues, and provide training to warehouse staff.
• Quality Assurance (QA): Conduct periodic audits to ensure ERP data matches physical storage locations.

4. Accountability

The Warehouse Manager is accountable for ensuring that storage locations are accurately updated in the ERP system, while the QA Manager is responsible for verifying compliance with regulatory standards through regular audits.

5. Procedure

5.1 Recording Storage Locations in ERP

1. Receiving Raw Materials:
   • Upon receiving raw materials, warehouse personnel must log into the ERP system using their assigned credentials.
   • Enter the material details, including material name, batch number, quantity, and received date.
   • Select the designated storage location from the system dropdown or manually input the location code.
   • Confirm and save the entry in the ERP system.
   • Document the receiving details in the ERP Update Log (Annexure-1).
2. Relocating Materials within the Warehouse:
   • When materials are relocated within the warehouse, update the new storage location in the ERP system immediately.
   • Ensure that both the previous and new locations are correctly recorded to maintain an audit trail.
   • Document relocation activities in the Material Relocation Log (Annexure-2).

5.2 Verifying ERP Data Accuracy

1. Daily Verification:
   • Warehouse personnel must cross-check physical inventory with ERP records at the end of each shift.
   • Any discrepancies must be reported to the Warehouse Manager for immediate correction.
   • Document verification activities in the Daily Verification Log (Annexure-3).
2. Periodic Audits:
   • QA personnel will conduct monthly audits to ensure ERP records match physical inventory locations.
   • Identify and investigate any discrepancies found during audits.
   • Document audit findings in the ERP Audit Log (Annexure-4).

5.3 Troubleshooting ERP Issues

1. System Errors and Data Loss:
   • In case of system errors, warehouse personnel must immediately notify the IT department.
   • IT personnel will investigate, resolve technical issues, and restore lost data from backups if necessary.
   • Document system errors and resolutions in the ERP Troubleshooting Log (Annexure-5).
2. Training and User Support:
   • IT personnel will provide periodic training to warehouse staff on ERP functionalities and updates.
   • Document training sessions in the ERP Training Log (Annexure-6).

5.4 Handling Deviations and Corrective Actions

1. Reporting Data Discrepancies:
   • Immediately report any data discrepancies, such as incorrect storage locations or missing entries, to the Warehouse Manager and QA.
   • Document discrepancies in the Data Discrepancy Log (Annexure-7).
2. Corrective Actions:
   • Investigate the cause of discrepancies and implement corrective actions, such as data correction, staff retraining, or process adjustments.
   • Document corrective actions in the Corrective Action Log (Annexure-8).

6. Abbreviations

• SOP: Standard Operating Procedure
• ERP: Enterprise Resource Planning
• GMP: Good Manufacturing Practice
• QA: Quality Assurance

7. Documents

1. ERP Update Log (Annexure-1)
2. Material Relocation Log (Annexure-2)

8. References

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

9. SOP Version

Version: 2.0

10. Approval Section

11. Annexures

Annexure-1: ERP Update Log

Annexure-2: Material Relocation Log

Revision History:

Standard Operating Procedure for Handling Material Spills in Storage Areas

1. Purpose

This Standard Operating Procedure (SOP) outlines the procedures for safely handling material spills in storage areas to prevent contamination, ensure safety, and maintain compliance with Good Manufacturing Practices (GMP).

2. Scope

This SOP applies to all types of raw material spills, including hazardous, non-hazardous, liquid, and solid materials occurring in the warehouse storage areas.

3. Responsibilities

• Warehouse Personnel: Immediately report spills, initiate containment procedures, and assist in cleanup following safety protocols.
• Warehouse Manager: Supervise spill response activities, ensure proper documentation, and implement corrective actions.
• Quality Assurance (QA): Verify that spill cleanup procedures meet GMP standards and conduct post-cleanup inspections.
• Safety Officer: Ensure appropriate use of personal protective equipment (PPE) and compliance with safety regulations during spill response.

4. Accountability

The Warehouse Manager is accountable for implementing spill response procedures, while the QA Manager ensures compliance with regulatory standards and verifies cleanup effectiveness.

5. Procedure

5.1 Spill Identification and Immediate Actions

1. Spill Identification:
   • Identify the material involved in the spill and assess the hazard level based on the Material Safety Data Sheet (MSDS).
   • Classify spills as minor (non-hazardous) or major (hazardous or involving large quantities).
   • Document spill identification in the Spill Incident Log (Annexure-1).
2. Immediate Containment:
   • For minor spills, use absorbent materials to contain and prevent the spread of the spill.
   • For major spills, evacuate the area immediately, activate emergency alarms, and notify the Safety Officer.
   • Secure the spill area with warning signs and barriers to prevent unauthorized access.
   • Record containment actions in the Containment Log (Annexure-2).

5.2 Spill Cleanup Procedures

1. Personal Protective Equipment (PPE):
   • Ensure all personnel involved in spill cleanup wear appropriate PPE, including gloves, masks, goggles, and protective clothing.
   • Document PPE usage in the PPE Compliance Log (Annexure-3).
2. Cleanup of Non-Hazardous Spills:
   • Use absorbent pads, paper towels, or spill kits to clean up non-hazardous spills.
   • Place contaminated materials in designated waste disposal bags and label appropriately.
   • Document non-hazardous cleanup activities in the Non-Hazardous Spill Cleanup Log (Annexure-4).
3. Cleanup of Hazardous Spills:
   • For hazardous spills, use specialized spill kits containing neutralizing agents, absorbents, and chemical-resistant tools.
   • Ensure proper ventilation in the spill area to prevent inhalation of harmful vapors.
   • Place hazardous waste in labeled, sealed containers and arrange for disposal according to regulatory guidelines.
   • Document hazardous spill cleanup activities in the Hazardous Spill Cleanup Log (Annexure-5).

5.3 Post-Cleanup Activities

1. Inspection and Verification:
   • QA personnel must inspect the spill area to ensure complete cleanup and absence of contamination.
   • Document inspection results in the Post-Cleanup Inspection Log (Annexure-6).
2. Restocking and Labeling:
   • Repackage and relabel any salvaged materials, ensuring they meet quality standards before returning to storage.
   • Document restocking activities in the Restocking Log (Annexure-7).

5.4 Handling Deviations and Corrective Actions

1. Reporting Deviations:
   • Report any deviations, such as inadequate spill containment or failure to follow PPE protocols, to the Warehouse Manager and QA.
   • Document deviations in the Deviation Log (Annexure-8).
2. Corrective Actions:
   • Investigate the cause of the deviation and implement corrective measures, such as retraining staff or updating spill response procedures.
   • Document corrective actions in the Corrective Action Log (Annexure-9).

6. Abbreviations

• SOP: Standard Operating Procedure
• GMP: Good Manufacturing Practice
• QA: Quality Assurance
• MSDS: Material Safety Data Sheet
• PPE: Personal Protective Equipment

7. Documents

1. Spill Incident Log (Annexure-1)
2. Containment Log (Annexure-2)
3. PPE Compliance Log (Annexure-3)
4. Non-Hazardous Spill Cleanup Log (Annexure-4)
5. Hazardous Spill Cleanup Log (Annexure-5)
6. Post-Cleanup Inspection Log (Annexure-6)
7. Restocking Log (Annexure-7)
8. Deviation Log (Annexure-8)
9. Corrective Action Log (Annexure-9)

8. References

• 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals
• WHO GMP Guidelines
• OSHA Hazardous Materials Handling Standards

9. SOP Version

Version: 2.0

10. Approval Section

11. Annexures

Annexure-1: Spill Incident Log

Annexure-2: Containment Log

Revision History:

Standard Operating Procedure for Handling and Storing Raw Materials in Large Drums and Carboys

1. Purpose

This Standard Operating Procedure (SOP) outlines the guidelines for safely handling and storing raw materials in large drums and carboys to ensure material integrity, prevent contamination, and maintain compliance with Good Manufacturing Practices (GMP).

2. Scope

This SOP applies to all raw materials stored in large drums and carboys, including solvents, chemicals, and other bulk materials received and stored in the warehouse.

3. Responsibilities

• Warehouse Personnel: Responsible for the proper handling, inspection, and storage of raw materials in large drums and carboys.
• Warehouse Manager: Oversee receiving, handling, and storage operations to ensure adherence to this SOP.
• Quality Assurance (QA): Inspect storage practices, verify compliance with specifications, and approve storage conditions.

4. Accountability

The Warehouse Manager is accountable for implementing safe handling and storage procedures, while the QA Manager ensures compliance with regulatory and quality standards.

5. Procedure

5.1 Receiving and Inspection

1. Inspection at Receipt:
   • Inspect large drums and carboys upon arrival for visible damage, leaks, or signs of contamination.
   • Ensure packaging integrity, such as intact seals and secure closures.
   • Verify materials against the purchase order and accompanying documentation (e.g., Certificate of Analysis, MSDS).
   • Document findings in the Receiving Inspection Log (Annexure-1).
2. Verification of Documentation:
   • Check batch numbers, expiry dates, and specifications on the delivery documentation.
   • Ensure all materials have the appropriate regulatory certificates and safety data sheets.
   • Record documentation verification in the Document Compliance Log (Annexure-2).

5.2 Handling of Large Drums and Carboys

1. Use of Handling Equipment:
   • Use forklifts, drum trolleys, or pallet jacks designed for handling heavy loads to transport drums and carboys.
   • Ensure equipment is regularly inspected and maintained for safe operation.
   • Document equipment usage in the Handling Equipment Log (Annexure-3).
2. Manual Handling Procedures:
   • If manual handling is necessary, ensure that two or more trained personnel are involved.
   • Use proper lifting techniques to prevent injury or material spillage.
   • Record manual handling activities in the Manual Handling Log (Annexure-4).

5.3 Storage of Large Drums and Carboys

1. Storage Conditions:
   • Store drums and carboys upright on pallets to prevent direct contact with the floor and ensure stability.
   • Secure drums and carboys with straps or barriers to prevent movement during storage.
   • Document storage conditions in the Storage Log (Annexure-5).
2. Segregation and Labeling:
   • Segregate materials based on their nature (flammable, corrosive, etc.) and store in designated areas with appropriate signage.
   • Ensure all containers are labeled with material name, batch number, expiry date, and hazard information.
   • Record segregation and labeling compliance in the Segregation and Labeling Log (Annexure-6).

5.4 Environmental Controls

1. Temperature and Humidity Control:
   • Monitor storage conditions to ensure materials are kept within specified temperature and humidity ranges.
   • Document environmental conditions in the Temperature and Humidity Log (Annexure-7).
2. Airflow and Ventilation:
   • Ensure proper airflow in storage areas to prevent the accumulation of vapors and maintain material integrity.
   • Conduct regular inspections of ventilation systems and document in the Environmental Control Log (Annexure-8).

5.5 Handling Deviations and Corrective Actions

1. Reporting Deviations:
   • Immediately report any deviations, such as damaged containers, improper storage, or unsafe handling, to the Warehouse Manager and QA.
   • Document deviations in the Deviation Log (Annexure-9).
2. Corrective Actions:
   • Investigate the cause of deviations and implement corrective actions such as re-labeling, relocating materials, or retraining staff.
   • Document corrective actions in the Corrective Action Log (Annexure-10).

6. Abbreviations

• SOP: Standard Operating Procedure
• GMP: Good Manufacturing Practice
• QA: Quality Assurance
• COA: Certificate of Analysis
• MSDS: Material Safety Data Sheet

7. Documents

1. Receiving Inspection Log (Annexure-1)
2. Document Compliance Log (Annexure-2)

8. References

• 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals
• WHO GMP Guidelines
• OSHA Standards for Safe Material Handling

9. SOP Version

Version: 2.0

10. Approval Section

11. Annexures

Annexure-1: Receiving Inspection Log

Annexure-2: Document Compliance Log

Revision History:

Standard Operating Procedure for Receiving and Storing Raw Materials in Different Packaging Forms

1. Purpose

This Standard Operating Procedure (SOP) provides detailed instructions for the proper receiving and storage of raw materials arriving in various packaging forms to ensure material integrity, prevent contamination, and maintain compliance with Good Manufacturing Practices (GMP).

2. Scope

This SOP applies to all raw materials received in drums, bags, carboys, cartons, and other packaging forms at the warehouse.

3. Responsibilities

• Warehouse Personnel: Ensure proper handling, inspection, and storage of raw materials based on packaging type.
• Warehouse Manager: Supervise receiving and storage operations, ensuring adherence to this SOP.
• Quality Assurance (QA): Inspect raw materials, verify compliance with specifications, and approve storage conditions.

4. Accountability

The Warehouse Manager is accountable for implementing proper receiving and storage procedures, while the QA Manager ensures compliance with regulatory and quality standards.

5. Procedure

5.1 Receiving Raw Materials

1. Inspection at Receipt:
   • Inspect all raw material consignments upon arrival for visible damage, contamination, or leakage.
   • Verify packaging integrity (e.g., sealed drums, intact bags) and ensure materials match purchase orders.
   • Document findings in the Receiving Inspection Log (Annexure-1).
2. Verification of Documentation:
   • Check accompanying documents such as the Certificate of Analysis (COA), Material Safety Data Sheet (MSDS), and delivery challans.
   • Ensure batch numbers, quantities, and specifications match the received materials.
   • Document verification in the Document Compliance Log (Annexure-2).

5.2 Handling and Storage Based on Packaging Forms

1. Storage of Drums:
   • Store drums on pallets to prevent direct contact with the floor and ensure stability to prevent rolling.
   • Keep flammable or hazardous materials in designated areas with proper ventilation and labeling.
   • Document storage details in the Drum Storage Log (Annexure-3).
2. Storage of Bags:
   • Stack bags neatly on pallets, ensuring they are not overstacked to avoid crushing.
   • Protect bags from moisture by storing them in dry areas or using moisture barriers.
   • Record storage information in the Bag Storage Log (Annexure-4).
3. Storage of Carboys:
   • Store carboys upright and secure them to prevent tipping or spillage.
   • Label carboys clearly with contents, batch numbers, and handling instructions.
   • Document storage in the Carboy Storage Log (Annexure-5).
4. Storage of Cartons and Other Forms:
   • Stack cartons on shelves or pallets, ensuring labels are visible for easy identification.
   • Ensure that fragile materials are stored in designated areas with appropriate signage.
   • Record storage details in the General Packaging Storage Log (Annexure-6).

5.3 Labeling and Segregation

1. Labeling Requirements:
   • Ensure all packaging forms are labeled with material name, batch number, expiry date, and storage instructions.
   • Use color-coded labels for high-risk or sensitive materials.
   • Document labeling compliance in the Label Verification Log (Annexure-7).
2. Segregation of Materials:
   • Segregate raw materials based on their status: Quarantined, Approved, and Rejected.
   • Store incompatible materials separately to prevent cross-contamination.
   • Document segregation practices in the Material Segregation Log (Annexure-8).

5.4 Environmental Controls

1. Temperature and Humidity Control:
   • Monitor storage conditions daily to ensure materials are kept within specified temperature and humidity ranges.
   • Document environmental conditions in the Temperature and Humidity Log (Annexure-9).
2. Airflow and Ventilation:
   • Ensure proper airflow in storage areas to prevent condensation and maintain material integrity.
   • Conduct periodic inspections of ventilation systems and document in the Environmental Control Log (Annexure-10).

5.5 Handling Deviations and Corrective Actions

1. Reporting Deviations:
   • Immediately report any deviations, such as damaged packaging or incorrect storage, to the Warehouse Manager and QA.
   • Document deviations in the Deviation Log (Annexure-11).
2. Corrective Actions:
   • Investigate the cause of deviations and implement corrective actions, such as re-labeling or relocating materials.
   • Document corrective actions in the Corrective Action Log (Annexure-12).

6. Abbreviations

• SOP: Standard Operating Procedure
• GMP: Good Manufacturing Practice
• QA: Quality Assurance
• COA: Certificate of Analysis
• MSDS: Material Safety Data Sheet

7. Documents

1. Receiving Inspection Log (Annexure-1)
2. Document Compliance Log (Annexure-2)
3. Drum Storage Log (Annexure-3)
4. Bag Storage Log (Annexure-4)
5. Carboy Storage Log (Annexure-5)
6. General Packaging Storage Log (Annexure-6)
7. Label Verification Log (Annexure-7)
8. Material Segregation Log (Annexure-8)
9. Temperature and Humidity Log (Annexure-9)
10. Environmental Control Log (Annexure-10)
11. Deviation Log (Annexure-11)
12. Corrective Action Log (Annexure-12)

8. References

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

9. SOP Version

Version: 2.0

10. Approval Section

11. Annexures

Annexure-1: Receiving Inspection Log

Annexure-2: Document Compliance Log

Revision History: