discrepancies.

4. Accountability

The Warehouse Manager is responsible for the proper receipt and segregation of different API grades. The QA Manager holds the authority to approve materials for further processing, while the QC Manager ensures testing meets grade-specific standards. The Procurement Manager ensures that suppliers provide clear, accurate documentation for all grades received.

5. Procedure

5.1 Pre-Receipt Preparations

1. Supplier Documentation Verification: Procurement ensures that suppliers provide the following documents for each API grade:
   • Separate Certificates of Analysis (CoA) for each grade.
   • Batch-specific labeling and documentation.
   • Purchase Order (PO) reflecting the specific grades and quantities ordered.
2. Pre-Delivery Notification: Logistics informs Warehouse and QA of the expected delivery, specifying the different grades and quantities of the API.

5.2 Receipt and Inspection of Different API Grades

1. Initial Material Verification by Warehouse:
   • Upon delivery, Warehouse personnel verify the following:
     • Material identity and grade as per the shipping documents.
     • Batch numbers and quantities for each grade.
     • Packaging integrity and labeling accuracy.
   • Document the receipt details in the API Receipt Log (Annexure-1).
2. Segregation of API Grades:
   • Segregate different grades of the API physically in the quarantine area to prevent cross-contamination or mix-ups.
   • Label each grade clearly with “UNDER TEST” status, batch number, and grade-specific information.

5.3 Quality Control Testing

1. Sampling Procedure:
   • QC personnel sample each grade separately, following standard sampling procedures.
   • Document sampling details in the API Sampling Log (Annexure-2).
2. Grade-Specific Testing:
   • Conduct tests specific to each grade, such as particle size analysis for micronized grades or purity testing for high-purity grades.
   • Record the testing results in the QC Test Report (Annexure-3).

5.4 Approval and Final Disposition

1. QA Review and Approval:
   • QA reviews the test reports and documentation for each API grade.
   • Approve compliant grades for use and move them to the appropriate storage area.
   • Reject non-compliant grades and move them to the rejection area, documenting in the API Disposition Log (Annexure-4).

5.5 Handling Discrepancies

1. Identification and Documentation of Discrepancies:
   • Any discrepancies in quantity, labeling, or documentation are recorded in the Discrepancy Report (Annexure-5).
   • Warehouse notifies QA and Procurement to investigate the discrepancies.
2. Corrective Actions:
   • Procurement contacts the supplier to resolve discrepancies.
   • QA reviews the corrective actions before final material disposition.

6. Abbreviations

• SOP: Standard Operating Procedure
• GMP: Good Manufacturing Practice
• API: Active Pharmaceutical Ingredient
• QA: Quality Assurance
• QC: Quality Control
• CoA: Certificate of Analysis
• PO: Purchase Order

7. Documents

1. API Receipt Log (Annexure-1)
2. API Sampling Log (Annexure-2)
3. QC Test Report (Annexure-3)
4. API Disposition Log (Annexure-4)
5. Discrepancy Report (Annexure-5)

8. References

• 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals
• ICH Q7 – Good Manufacturing Practice for Active Pharmaceutical Ingredients
• EU Guidelines on Good Distribution Practices (GDP)

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: API Receipt Log

Date	API Name	Grade	Batch Number	Quantity Received	Packaging Condition	Received By
01/02/2025	API-X	Micronized	X-2025-001	100 kg	Intact	John Doe
01/02/2025	API-X	Non-Micronized	X-2025-002	150 kg	Intact	Jane Smith

Annexure-2: API Sampling Log

Date	API Name	Grade	Batch Number	Sampled By	Sample ID	Remarks
02/02/2025	API-X	Micronized	X-2025-001	Mark Lee	SAMP-001	Sent to QC
02/02/2025	API-X	Non-Micronized	X-2025-002	Anna White	SAMP-002	Sent to QC

Annexure-3: QC Test Report

Date	API Name	Grade	Batch Number	Test Performed	Result	Conclusion
03/02/2025	API-X	Micronized	X-2025-001	Particle Size	Pass	Approved
03/02/2025	API-X	Non-Micronized	X-2025-002	Purity Test	Pass	Approved

Annexure-4: API Disposition Log

Date	API Name	Grade	Batch Number	Disposition	Approved By	Remarks
04/02/2025	API-X	Micronized	X-2025-001	Approved	QA Manager	Meets Specifications
04/02/2025	API-X	Non-Micronized	X-2025-002	Approved	QA Manager	Meets Specifications

Annexure-5: Discrepancy Report

Date	API Name	Grade	Batch Number	Discrepancy	Reported By	Corrective Action	Status
02/02/2025	API-X	Micronized	X-2025-001	Labeling Error	John Doe	Supplier Corrected Labeling	Closed

Revision History:

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By
01/01/2024	1.0	Initial Version	New SOP	QA Head
01/02/2025	2.0	Added Discrepancy Handling Procedures	Standardization	QA Head