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).

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

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Receiving Inspection Log

Date	Material Name	Packaging Type	Condition at Receipt	Inspected By
25/02/2025	API A	Drum	Good	Ravi Kumar

Annexure-2: Document Compliance Log

Date	Material Name	Document Type	Status	Verified By
25/02/2025	API A	COA	Verified	Sunita Sharma

Revision History:

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By
01/01/2024	1.0	Initial Version	New SOP	QA Head
25/02/2025	2.0	Updated Procedures for Different Packaging Forms	Regulatory Compliance	QA Head