Standard Operating Procedure for Raw Material Issuance Based on Batch Manufacturing Record (BMR)

Department	Warehouse / Production / Quality Assurance
SOP No.	SOP/RM/196/2025
Supersedes	SOP/RM/196/2022
Page No.	Page 1 of 15
Issue Date	01/05/2025
Effective Date	08/05/2025
Review Date	01/05/2026

1. Purpose

This Standard Operating Procedure (SOP) outlines the process for the accurate issuance of raw materials from the warehouse to production based on the Batch Manufacturing Record (BMR) to ensure traceability, compliance with Good Manufacturing Practices (GMP), and product quality.

2. Scope

This SOP applies to all warehouse, production, and quality assurance personnel involved in the issuance, verification, and documentation of raw materials based on BMR requirements.

3. Responsibilities

• Warehouse Staff: Issue raw materials according to BMR specifications and ensure accurate documentation.
• Production Supervisor: Verify that issued materials match BMR requirements before use in production.
• Quality Assurance (QA) Team: Oversee compliance with issuance protocols and perform audits.

4. Accountability

The Warehouse Manager is accountable for the proper issuance of raw materials. The Production Supervisor ensures that only correctly issued materials are used in manufacturing, while the QA Manager verifies compliance through regular audits.

5. Procedure

5.1 Receipt and Review of BMR

1. BMR Submission:
   • The Production Department submits the approved BMR to the Warehouse for raw material issuance.
   • Record BMR receipt in the BMR Receipt Log (Annexure-1).
2. BMR Review:
   • The Warehouse Supervisor reviews the BMR for completeness and authorization before issuing materials.
   • Document BMR review details in the BMR Review Log (Annexure-2).

5.2 Raw Material Issuance Process

1. Material Selection:
   • Select raw materials based on the batch number, quantity, and specifications in the BMR, following FIFO (First-In, First-Out) or FEFO (First-Expiry, First-Out) principles.
   • Record material selection in the Material Selection Log (Annexure-3).
2. Material Weighing:
   • Weigh the raw materials according to the BMR instructions using calibrated equipment.
   • Document weighing details in the Weighing Log (Annexure-4).

5.3 Verification and Documentation

1. Cross-Verification:
   • The Production Supervisor or designated QA personnel verifies the materials against the BMR for correct batch numbers, quantities, and specifications.
   • Log verification details in the Verification Log (Annexure-5).
2. Labeling of Issued Materials:
   • Label the issued materials with the batch number, material name, and weight as per BMR requirements.
   • Document labeling in the Material Labeling Log (Annexure-6).

5.4 Handling Discrepancies

1. Identification of Discrepancies:
   • Any discrepancies between issued materials and BMR specifications must be reported immediately to the QA team.
   • Document discrepancies in the Discrepancy Log (Annexure-7).
2. Corrective Actions:
   • Implement corrective actions for discrepancies, and document resolutions in the Corrective Action Log (Annexure-8).

5.5 Training and Compliance Monitoring

1. Staff Training:
   • Conduct training sessions on the proper issuance of raw materials based on BMR.
   • Document training sessions in the Training Log (Annexure-9).
2. Compliance Audits:
   • QA personnel conduct periodic audits to ensure compliance with issuance procedures.
   • Record audit findings in the Compliance Audit Log (Annexure-9).

6. Abbreviations

• SOP: Standard Operating Procedure
• BMR: Batch Manufacturing Record
• QA: Quality Assurance
• FIFO: First-In, First-Out
• FEFO: First-Expiry, First-Out

7. Documents

1. BMR Receipt Log (Annexure-1)
2. BMR Review Log (Annexure-2)
3. Material Selection Log (Annexure-3)
4. Weighing Log (Annexure-4)
5. Verification Log (Annexure-5)
6. Material Labeling Log (Annexure-6)
7. Discrepancy Log (Annexure-7)
8. Corrective Action Log (Annexure-8)
9. Training Log (Annexure-9)

8. References

• 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals
• WHO Guidelines on GMP for Pharmaceutical Products
• FDA Guidance on Batch Manufacturing Record Management

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

Annexure-1: BMR Receipt Log

Date	BMR Number	Received By	Production Batch Number
01/05/2025	BMR-45678	Ravi Kumar	PB-00123

Annexure-2: BMR Review Log

Date	BMR Number	Reviewed By	Remarks
01/05/2025	BMR-45678	Neha Verma	Complete and Authorized

Annexure-3: Material Selection Log

Date	Material Name	Batch Number	Selected By
01/05/2025	Acetaminophen API	BN-78901	Amit Joshi

Annexure-4: Weighing Log

Date	Material Name	Weighed Quantity (kg)	Weighed By
01/05/2025	Acetaminophen API	25 kg	Kiran Patel

Annexure-5: Verification Log

Date	Material Name	Batch Number	Verified By
01/05/2025	Acetaminophen API	BN-78901	QA Team

Annexure-6: Material Labeling Log

Date	Material Name	Label Information	Labeled By
01/05/2025	Acetaminophen API	Batch BN-78901, 25 kg	Ravi Kumar

Annexure-7: Discrepancy Log

Date	Discrepancy Identified	Description	Reported By
01/05/2025	Incorrect Batch Number	Mismatch between BMR and issued material	QA Team

Annexure-8: Corrective Action Log

Date	Issue	Corrective Action Taken	Performed By
01/05/2025	Incorrect Batch Issuance	Re-issued correct batch	Warehouse Staff

Annexure-9: Training Log

Date	Employee Name	Training Topic	Trainer	Remarks
01/05/2025	Neha Verma	Raw Material Issuance Based on BMR	QA Manager	Completed Successfully

Revision History:

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By
01/01/2024	1.0	Initial Version	New SOP Implementation	QA Head
01/05/2025	2.0	Added procedures for discrepancy handling and corrective actions.	Regulatory Update	QA Head