and batch discrepancies.

2. Scope

This SOP is applicable to all cross-verification activities performed by designated personnel following material dispensing and prior to issuance to production within the sterile injectable manufacturing facility.

3. Responsibilities

• Stores Chemist: Dispenses materials and presents them for verification.
• QA Executive: Performs independent cross-verification of each dispensed item and signs off documentation.
• Production Pharmacist: Confirms material receipt matches BMR and verification records.

4. Accountability

The Head of QA is accountable for ensuring that cross-verification is performed for every dispensed material and no unverified material is transferred to manufacturing areas.

5. Procedure

5.1 Prerequisites

1. Ensure the Material Requisition Note (MRN) and approved Batch Manufacturing Record (BMR) are available.
2. Check that dispensing records are complete and weights recorded.
3. Ensure all labels are affixed and legible on dispensed containers.

5.2 Cross-Verification Steps

1. Verify the following attributes against the BMR and MRN:
   • Material name and code
   • Material batch/lot number
   • Quantity dispensed (weighed quantity vs. required)
   • Status label (“Approved” and valid)
   • Container label details (name, batch no., container no., date)
2. Ensure that the quantity dispensed is within ±0.1% of the specified amount.
3. Confirm physical integrity of the packaging (cleanliness, no tears, correct closure).

5.3 Documentation

1. Record verification results in the Cross-Verification Log (Annexure-1).
2. QA to sign and date next to each verified container and complete Verification Summary Form (Annexure-2).

5.4 Handling Discrepancies

1. If any mismatch or labeling error is observed, do not release the material.
2. Inform the QA Manager and raise a Dispensing Deviation Report (Annexure-3).
3. Perform corrective action, re-dispense if necessary, and document justification.

6. Abbreviations

• SOP: Standard Operating Procedure
• QA: Quality Assurance
• MRN: Material Requisition Note
• BMR: Batch Manufacturing Record

7. Documents

1. Cross-Verification Log – Annexure-1
2. Verification Summary Form – Annexure-2
3. Dispensing Deviation Report – Annexure-3

8. References

• WHO TRS 986 Annex 2 – GMP for Pharmaceutical Products
• ICH Q10 – Pharmaceutical Quality System
• Schedule M – Indian GMP

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation	Warehouse Executive	QA Executive	Head – QA
Department	Warehouse	Quality Assurance	Quality Assurance

11. Annexures

Annexure-1: Cross-Verification Log

Date	Material	Batch No.	Qty	Verified By	Remarks
17/06/2025	Sodium Bicarbonate	BN-SB025	2.0 kg	Sunita Reddy	Verified OK

Annexure-2: Verification Summary Form

BMR No.	BMR/SIM/025
Material Verified	Sodium Bicarbonate
Qty Dispensed	2.0 kg
Date	17/06/2025
Verified By (QA)	Sunita Reddy

Annexure-3: Dispensing Deviation Report

Date	Reference No.	Deviation	Corrective Action	Approved By
17/06/2025	DDR/2025/014	Label mismatch	Reprint and reverify	QA Manager

Revision History

Revision Date	Revision No.	Details	Reason	Approved By
15/02/2022	1.0	Initial Issue	New SOP	QA Head
17/06/2025	2.0	Verification summary and deviation tracking added	Annual Review	QA Head