documenting actions, evaluating recall efficiency, and reporting outcomes.

3. Responsibilities

• QA Head: Approves and authorizes the execution of mock recalls and reviews the final report.
• Recall Coordinator (Designated QA Executive): Plans and executes the mock recall and maintains records.
• Warehouse/Logistics: Provides distribution data and helps trace batches.
• Regulatory Affairs: Ensures compliance with regulatory expectations during recall simulation.
• All Department Heads: Cooperate in providing data and ensuring smooth execution of mock recalls.

4. Accountability

The Quality Assurance Department is accountable for the implementation, effectiveness monitoring, and continuous improvement of the recall system.

5. Procedure

5.1 Frequency and Planning

1. Mock recalls shall be conducted at least once annually or as required by regulatory bodies.
2. The schedule for mock recall shall be defined in the Annual Quality Plan and approved by QA Head.
3. The selection of product and batch for mock recall shall be random but should cover a range of APIs over the years.

5.2 Initiation

1. The Recall Coordinator shall initiate the process using the Mock Recall Initiation Form (Annexure-1), which must include:
   • Selected Product Name
   • Batch Number
   • Manufacture and Expiry Date
   • Reason for Simulation
2. The QA Head shall approve and authorize the simulation.

5.3 Notification and Team Formation

1. Constitute a Mock Recall Team including representatives from QA, Warehouse, Production, and Regulatory Affairs.
2. Issue internal communication to all relevant departments regarding the exercise, ensuring confidentiality and traceability.

5.4 Distribution Traceability

1. Warehouse/Logistics shall provide the Distribution Log (Annexure-2) showing:
   • Customers or locations where batch was dispatched
   • Date of dispatch
   • Quantity shipped
   • Contact details
2. The Recall Coordinator shall simulate retrieval of product using this information and document the results in the Mock Recall Execution Sheet (Annexure-3).

5.5 Reconciliation and Effectiveness

1. Calculate:
   • Total quantity manufactured
   • Total quantity distributed
   • Quantity available in warehouse
   • Simulated recalled quantity
2. Evaluate effectiveness based on traceability rate (minimum acceptable: ≥95%).
3. Record findings in the Mock Recall Evaluation Report (Annexure-4).

5.6 Documentation and Review

1. QA shall compile all forms, logs, and findings into a single recall file.
2. The final report shall include:
   • Observations
   • Shortcomings (if any)
   • Corrective actions
3. QA Head and Site Head shall review and approve the final Mock Recall Summary Report (Annexure-5).

5.7 Corrective Actions and Follow-Up

1. If deficiencies are found (e.g., untraceable quantity, delayed responses), initiate CAPA using CAPA Form (Annexure-6).
2. Follow-up must be conducted to ensure all corrective actions are implemented within 30 days.

6. Abbreviations

• QA: Quality Assurance
• CAPA: Corrective and Preventive Action
• APQR: Annual Product Quality Review
• SOP: Standard Operating Procedure

7. Documents

1. Mock Recall Initiation Form (Annexure-1)
2. Distribution Log (Annexure-2)
3. Mock Recall Execution Sheet (Annexure-3)
4. Mock Recall Evaluation Report (Annexure-4)
5. Mock Recall Summary Report (Annexure-5)
6. CAPA Form (Annexure-6)

8. References

• ICH Q10 – Pharmaceutical Quality System
• 21 CFR Part 211.150 – Distribution Records
• EU GMP Chapter 8 – Complaints and Product Recall

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Mock Recall Initiation Form

Product	Batch No.	Mfg Date	Exp Date	Reason
API-X	AXP2025	10/02/2025	10/02/2028	Mock Recall – System Evaluation

Annexure-2: Distribution Log

Customer	Address	Batch No.	Qty (kg)	Dispatch Date
XYZ Pharma	Pune	AXP2025	50	15/02/2025

Annexure-3: Mock Recall Execution Sheet

Location	Contacted By	Date/Time	Response Time	Qty Traceable
XYZ Pharma	Sunita Reddy	12/04/2025 10:00 AM	2 hrs	50 kg

Annexure-4: Mock Recall Evaluation Report

Parameter	Target	Achieved	Remarks
Traceability Rate	≥95%	100%	Effective
Response Time	≤4 hrs	2 hrs	Compliant

Annexure-5: Mock Recall Summary Report

Recall ID	Date	Coordinator	Outcome	Approved By
MR/2025/01	12/04/2025	Rajesh Kumar	Successful	QA Head

Annexure-6: CAPA Form

CAPA No.	Issue Identified	Corrective Action	Owner	Status
CAPA/2025/07	Late response by warehouse	Refresher training scheduled	Warehouse Head	Open

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
01/01/2022	1.0	Initial SOP	New creation	QA Head
14/04/2025	2.0	Added CAPA and Summary annexures	Audit Feedback	QA Head