PROTOCOL
FOR
MOCK RECALL VALIDATION
PREPARED BY :
FUNCTION NAME SIGNATURE DATE
Quality Assurance
REVIEWED & APPROVED BY:
FUNCTION NAME SIGNATURE DATE
Quality Assurance
Production
Store
Quality Assurance
TABLE OF CONTENTS
SR. NO. TITLE PAGE NO.
1.0 OBJECTIVE 4
2.0 SCOPE 4
3.0 RATIONAL 4
4.0 RESPONSIBILTY 4
5.0 POLICY 5
6.0 PROCEDURE 5-6
7.0 EVALUATION OF THE RESULTS 6
8.0 CONCLUSION 6
ANNEXURE - I 7
1.0 OBJECTIVE
The Objective of this protocol is to ensure the effectiveness of the recall procedure.
2.0 SCOPE
This protocol applies only to Products manufactured and marketed by Daxin Pharmaceuticals
Private Limited, Baddi for domestic market. (Mock Recall procedure for the Products
manufactured for Export mfg shall be governed by corresponding Marketing Authorization
Holder.
3.0 RATIONAL
This document shall demonstrate the mock recall study that, in case of any market complaint
and any serious problem related to stability is observed in the product, so that the product can be
recalled from the market .
4.0 RESPONSIBILITY
Responsibilities of individual functional areas are as follows:
Quality Assurance To prepare and approve the protocol
Implementation of protocol
Lead the whole validation team
Monitor the progress to ensure the completion of the
procedure
Approval of any protocol amendments, if necessary
Production Review and approval of protocol
To provide the support if any
Warehouse & Review and approval of protocol
To provide the all related information with the available
Distribution
quantity of the recalled product.
5.0 POLICY
Head QA shall be responsible for the administration of the ‘Mock Recall Study’.
The effectiveness of the procedure shall be checked by conducting a Mock Recall on one batch
of a product as distributed in India. Distribution flow and recording system of the product is as
follows:
Manufacturing Unit (Records in ERP)
Duty Paid Godown (DPG) (Records in ERP)
C&F / Super Stockiest (Records in Marg)
Stockiest / Retailer
Customer
6.0 PROCEDURE
6.1 For execution of the mock recall study, the QA Head shall send the electronic copy to the
manager Logistics & Distribution of the mock recall protocol for the clear understanding about
the study.
6.2 After conforming the satisfactory answer, the study shall be started as follows.
6.3 One product shall be selected for the execution of mock recall study.
6.4 The Batch manufacturing and packing record shall be reviewed of the selected batches.
6.5 Record Product details in Annexure – I, as follows:
Product name
Batch number / Mfg. Date / Expiry Date
Quantity dispatch including Pack profile
Dispatch date from the Plant
6.6 The procedure includes the mechanism to identify the distribution history up to C&F level of
the batch and to confirm the same C&F to Stockiest / Retailer (if applicable).
6.7 No contact will be made with Stockiest / Retailer and customers during the study.
6.8 After getting the batch distribution detail, QA personnel shall compile the data.
6.9 A statement shall be prepared after compilation of the distribution data and conclusion shall be
made by the Head – QA in Annexure-I.
7.0 EVALUATION OF THE RESULTS
Details of the distribution shall be obtained within 02 working days up to C&F and Stockiest /
Retailer (if applicable) level.
8.0 CONCLUSION
On completion of product recall simulation study, a clear statement shall be recorded in
Annexure – I, that the Mock Recall found to be satisfactory / not satisfactory and product recall
is effective / not effective.
ANNEXURE –I
Product Batch Mfg. Date Exp. Date Quantity Date of
Number Dispatched@ Dispatch
Details of the distribution filled based on data available from Logistics & Distribution Manager
Product Batch Quantity dispatched Reconciliation Remark
from DPG w.r.t. dispatched
Number
quantity @
Total Quantity
Remark: Complete information of the distribution up to C&F and Stockiest / Retailer was
reviewed. The Mock recall found satisfactory / not satisfactory and product recall is effective /
not effective
Prepared by / Date: Approved by (Head - QA) / Date:
