Standard Operating Procedure for Receiving and Managing Multiple Batches of the Same Raw Material

Department	Warehouse / Quality Assurance / Procurement / Quality Control
SOP No.	SOP/RM/051/2025
Supersedes	SOP/RM/051/2022
Page No.	Page 1 of 15
Issue Date	01/02/2025
Effective Date	05/02/2025
Review Date	01/02/2026

1. Purpose

This Standard Operating Procedure (SOP) defines the process for receiving, verifying, and managing multiple batches of the same raw material. It ensures proper identification, segregation, documentation, and compliance with Good Manufacturing Practices (GMP) to prevent mix-ups and maintain material integrity.

2. Scope

This SOP applies to all raw materials received in multiple batches under the same shipment or separate shipments. It includes procedures for receipt, inspection, sampling, documentation, and storage of Active Pharmaceutical Ingredients (APIs), excipients, solvents, and other raw materials.

3. Responsibilities

• Warehouse Personnel: Receive, inspect, and segregate multiple batches of raw materials. Ensure proper labeling and documentation.
• Quality Assurance (QA): Review and approve documentation, ensure compliance with GMP standards, and authorize material release.
• Quality Control (QC): Perform sampling and testing of each batch for compliance with specifications.
• Procurement Department: Ensure suppliers provide batch-specific documentation and resolve discrepancies.

4. Accountability

The Warehouse Manager is responsible for the accurate receipt and segregation of multiple batches. The QA Manager holds authority to approve or reject materials based on compliance. The QC Manager ensures that each batch meets the required specifications, while the Procurement Manager ensures the completeness and accuracy of supplier documentation.

5. Procedure

5.1 Pre-Receipt Preparations

1. Supplier Documentation:
   • Procurement ensures that suppliers provide individual Certificates of Analysis (CoA) and batch-specific documentation for each batch.
   • Logistics informs the Warehouse and QA teams about the expected arrival of multiple batches, including batch numbers and quantities.
2. Pre-Delivery Coordination:
   • Warehouse prepares for receipt by ensuring designated storage areas are available for batch segregation.

5.2 Receiving and Inspecting Multiple Batches

1. Initial Material Verification:
   • Warehouse personnel verify:
     • Material identity, batch numbers, and quantities against the delivery note.
     • Packaging integrity and proper labeling of each batch.
   • Document receipt details in the Multiple Batch Receipt Log (Annexure-1).
2. Segregation of Batches:
   • Physically segregate each batch in the quarantine area to prevent cross-contamination.
   • Label each batch with “UNDER TEST” status, batch number, and other relevant information.

5.3 Sampling and Testing of Multiple Batches

1. Sampling Procedure:
   • QC personnel perform sampling for each batch separately following standard sampling procedures.
   • Document sampling details in the Batch Sampling Log (Annexure-2).
2. Testing and Compliance:
   • Conduct required tests for each batch to ensure compliance with specifications.
   • Record test results in the Batch Test Report (Annexure-3).

5.4 Approval and Material Disposition

1. QA Review and Approval:
   • QA reviews the test reports and documentation for each batch.
   • Approve compliant batches for release to the storage area and reject non-compliant batches, documenting in the Batch Disposition Log (Annexure-4).

5.5 Handling Discrepancies

1. Identification and Documentation:
   • Any discrepancies in batch numbers, quantities, or documentation are recorded in the Discrepancy Report (Annexure-5).
   • Warehouse notifies QA and Procurement to resolve discrepancies.
2. Corrective Actions:
   • Procurement contacts the supplier for clarification or resolution.
   • QA ensures corrective actions are implemented before final approval or rejection.

6. Abbreviations

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

7. Documents

1. Multiple Batch Receipt Log (Annexure-1)
2. Batch Sampling Log (Annexure-2)
3. Batch Test Report (Annexure-3)
4. Batch 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: Multiple Batch Receipt Log

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

Annexure-2: Batch Sampling Log

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

Annexure-3: Batch Test Report

Date	Material Name	Batch Number	Test Performed	Result	Conclusion
03/02/2025	API-X	X-2025-001	Purity Test	Pass	Approved
03/02/2025	API-X	X-2025-002	Purity Test	Pass	Approved

Annexure-4: Batch Disposition Log

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

Annexure-5: Discrepancy Report

Date	Material Name	Batch Number	Discrepancy	Reported By	Corrective Action	Status
02/02/2025	API-X	X-2025-002	Incorrect Labeling	John Doe	Supplier Notified, Label Corrected	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