injectable products manufactured at the facility and covers the planning, execution, documentation, and evaluation of mock recall exercises.

3. Responsibilities

• QA Manager: Overall in-charge of the mock recall process and reporting outcomes.
• Recall Coordinator: Plans and executes the mock recall with cross-functional team support.
• Stores Department: Provides distribution and inventory data as required.
• Documentation Team: Maintains records and evaluates performance metrics.

4. Accountability

The Head of Quality is accountable for ensuring compliance with the mock recall procedure and reporting findings to senior management.

5. Procedure

5.1 Planning

1. QA shall plan one mock recall every year as part of the quality system review.
2. Select a product batch randomly from the list of released injectable products.
3. Prepare a Mock Recall Plan (Annexure-1) detailing objective, product details, team members, and recall strategy.

5.2 Execution

1. Initiate recall from dispatch records and simulate tracing the product down to distributor level.
2. Verify accuracy and completeness of:
   • Batch Manufacturing Record (BMR)
   • Batch Packing Record (BPR)
   • Distribution records
3. Document time taken to trace and locate all shipped quantities.
4. Complete the Mock Recall Execution Log (Annexure-2).

5.3 Evaluation

1. QA shall analyze gaps in documentation, traceability, and communication.
2. Summarize outcomes in a Mock Recall Evaluation Report (Annexure-3).
3. Share findings with Quality Head and senior management for review and training enhancement.

5.4 Closure

1. Prepare a Corrective and Preventive Action (CAPA) plan based on observations (Annexure-4).
2. Update the Mock Recall Register (Annexure-5).
3. Review this SOP annually based on outcomes.

6. Abbreviations

• SOP: Standard Operating Procedure
• QA: Quality Assurance
• BMR: Batch Manufacturing Record
• BPR: Batch Packing Record
• CAPA: Corrective and Preventive Action

7. Documents

1. Mock Recall Plan – Annexure-1
2. Execution Log – Annexure-2
3. Evaluation Report – Annexure-3
4. CAPA Plan – Annexure-4
5. Mock Recall Register – Annexure-5

8. References

• WHO TRS 996 Annex 3 – Good Manufacturing Practices
• 21 CFR Part 7 – Recall Procedures
• ICH Q10 – Pharmaceutical Quality System

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation	Manufacturing Executive	QA Executive	Head QA
Department	Production	Quality Assurance	Quality Assurance

11. Annexures

Annexure-1: Mock Recall Plan

Product	Batch No.	Recall Date	Team Lead
Injexol 250mg	BN25023	01/05/2025	Sunita Reddy

Annexure-2: Execution Log

Time Started	Distributor Traced	Quantity Found	Time Completed
09:00 AM	PharmaLink Distributors	500 vials	12:30 PM

Annexure-3: Evaluation Report

Observation	Impact	Recommendation
Delay in distributor contact	Moderate	Improve contact list accuracy

Annexure-4: CAPA Plan

Action	Responsible	Due Date	Status
Update recall SOP contact info	QA Manager	10/05/2025	Completed

Annexure-5: Mock Recall Register

Date	Batch	Product	Status	Remarks
01/05/2025	BN25023	Injexol 250mg	Completed	Effective

Revision History

Revision Date	Revision No.	Details	Reason	Approved By
10/04/2022	1.0	Initial Version	New SOP	QA Head
18/06/2025	2.0	Annexures revised, contact protocols added	Annual Review	QA Head