Standard Operating Procedure for Receiving and Inspection of Raw Materials in API Manufacturing

Department	API Manufacturing
SOP No.	SOP/API/002/2025
Supersedes	SOP/API/002/2022
Page No.	Page 1 of 11
Issue Date	13/04/2025
Effective Date	15/04/2025
Review Date	13/04/2026

1. Purpose

To outline a standardized procedure for receiving, verifying, and inspecting raw materials including APIs, excipients, solvents, and other ingredients used in API manufacturing. This ensures all received materials are checked for compliance, free from damage, correctly documented, and quarantined until tested and approved.

2. Scope

This SOP applies to warehouse personnel, quality assurance, and quality control teams involved in the receiving and inspection of raw materials at the API manufacturing facility.

3. Responsibilities

• Warehouse Assistant: Unload, physically inspect, and document incoming raw materials.
• QC Executive: Collect samples for quality testing and confirm packaging integrity.
• QA Officer: Verify documents, approve the quarantine area, and release for sampling.
• Purchase Officer: Coordinate delivery schedules and ensure vendor documents are available.

4. Accountability

The Warehouse Manager and QA Manager are accountable for implementing and monitoring the procedure to ensure GMP compliance and traceability of incoming raw materials.

5. Procedure

5.1 Material Arrival and Unloading

1. Verify that the receiving area is clean and designated only for material receipt.
2. Check the vehicle cleanliness and integrity before unloading. Reject deliveries if contamination is suspected.
3. Use clean forklifts or pallet trucks to unload the material containers.
4. Cross-check the delivery challan or invoice against the Purchase Order (PO).
5. Note any transit damage, spillage, wet bags, or broken seals in the delivery log.

5.2 Verification of Documents and Material Labeling

1. Collect and verify the following documents from the vendor:
   • Invoice
   • Certificate of Analysis (CoA)
   • Material Safety Data Sheet (MSDS)
   • GMP declaration or license
2. Ensure that each container is properly labeled with:
   • Material Name
   • Batch Number
   • Manufacturer Name
   • Manufacturing & Expiry Date
   • Net Weight
3. Affix a “Quarantine” label (red) with a unique material inward number and date.

5.3 Physical Inspection

1. Check packaging integrity: Look for any punctures, swelling, leakages, or corrosion.
2. Verify closure seals or tamper-evident tapes for signs of opening.
3. Match material quantity received with the PO and invoice.
4. Inspect label clarity, legibility, and compliance with predefined format.

5.4 Segregation and Quarantine

1. Move received materials to the “Quarantine” storage area.
2. Ensure temperature-sensitive materials are stored as per label instruction (e.g., 2–8°C).
3. Record all entries in the “Raw Material Receipt Log” (Annexure-1).
4. Notify QC to initiate sampling only after QA authorization.

5.5 Handling Discrepancies

1. If discrepancies such as wrong batch number, quantity mismatch, or damage are found:
   • Do not move materials to quarantine.
   • Tag them “On Hold” and place in a designated investigation area.
   • Initiate a “Material Discrepancy Form” (Annexure-2).
   • Investigate and document outcome with vendor follow-up.

5.6 Approval for Sampling

1. QA to review documents and physical inspection checklist.
2. Upon satisfactory review, QA shall authorize QC to collect samples.
3. Document QA approval in the “Material Inspection Log.”

6. Abbreviations

• QA: Quality Assurance
• QC: Quality Control
• PO: Purchase Order
• SOP: Standard Operating Procedure
• CoA: Certificate of Analysis
• MSDS: Material Safety Data Sheet

7. Documents

1. Raw Material Receipt Log (Annexure-1)
2. Material Discrepancy Form (Annexure-2)
3. Material Inspection Log (Annexure-3)

8. References

• ICH Q7: GMP Guide for Active Pharmaceutical Ingredients
• WHO TRS No. 986 Annex 2
• 21 CFR Part 211.80 – Components, drug product containers, and closures

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name	Rajesh Kumar	Sunita Reddy	Manoj Verma
Designation	Warehouse Officer	QA Executive	QA Manager
Department	API Manufacturing	Quality Assurance	Quality Assurance

11. Annexures

Annexure-1: Raw Material Receipt Log

Date	Material	Batch No.	Qty	Supplier	PO No.	Received By
13/04/2025	Citric Acid	CA20250413	50 kg	ABC Organics	PO-9876	Rajesh Kumar

Annexure-2: Material Discrepancy Form

Date	Material	Issue Observed	Action Taken	Remarks
13/04/2025	IPA	Broken Drum Seal	Segregated	Vendor informed

Annexure-3: Material Inspection Log

Date	Material	Batch	QA Review Status	Sampling Approved	Remarks
13/04/2025	Citric Acid	CA20250413	Verified	Yes	Ready for QC Sampling

Revision History:

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By
01/01/2022	1.0	Initial SOP	Procedure Establishment	QA Head
13/04/2025	2.0	Included discrepancy handling and annexures	Regulatory alignment	QA Head