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

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Bulk Liquid Receiving Log

Date	Material Name	Batch Number	Container Condition	Inspected By
28/02/2025	Solvent A	Batch1234	No Damage	Ravi Kumar

Annexure-2: Documentation Verification Log

Date	Material Name	Document Verified	Verified By
28/02/2025	Solvent A	COA, MSDS	Sunita Sharma

Annexure-3: Handling Equipment Log

Date	Equipment Used	Material Handled	Handled By
28/02/2025	Forklift	Solvent A	Amit Joshi

Annexure-4: Manual Handling Log

Date	Material Name	Batch Number	Handled By
28/02/2025	Solvent B	Batch5678	Neha Verma

Annexure-5: Storage Condition Log

Date	Material Name	Storage Temperature	Storage Location
28/02/2025	Solvent A	25°C	Warehouse A – Shelf 5

Annexure-6: Segregation and Labeling Log

Date	Material Name	Label Applied By	Segregation Area
28/02/2025	Solvent A	Priya Singh	Flammable Materials Section

Annexure-7: Spill Prevention Log

Date	Inspection Performed By	Findings	Corrective Actions Taken
28/02/2025	Ravi Kumar	No leaks found	N/A

Annexure-8: Spill Incident Log

Date	Material Name	Spill Description	Response Action	Reported By
28/02/2025	Solvent A	Minor spill during transfer	Contained with absorbent pads	Sunita Sharma

Annexure-9: Deviation Log

Date	Deviation Description	Reported By	Corrective Action Taken
28/02/2025	Improper labeling of solvent container	Amit Joshi	Relabeled correctly

Annexure-10: Corrective Action Log

Date	Corrective Action Description	Implemented By	Verified By
01/03/2025	Retraining on proper labeling procedures	Rajeev Menon	QA Head – Priya Singh

Revision History:

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By
01/01/2024	1.0	Initial Version	New SOP	QA Head
28/02/2025	2.0	Updated Procedures for Handling Bulk Liquids	Regulatory Compliance	QA Head