To lay down the procedure for conducting Mock Recall.
2.0
Scope :
Scope of this document is to follow procedure for Mock Recall.
3.0
Responsibility :
3.1
Quality Assurance Department for conducting, monitoring and administration of Mock Recall procedure.
4.0
Definition(s) of Mock Recall:
Mock recalls are routine exercises conducted by manufacturers, processors, distributors and other various trading partners in the supply chain to assess their recall procedures and responsiveness. Mock recall has to confirm the efficient collation of batch history details and effectiveness of communication channels.
5.0
Procedure :
5.1
No contact shall be made with customers, contract clients & Regulatory Agencies, unless specifically authorized by Head – QA.
5.2
Upon the direction of Head – QA or his designee “Mock Recall” shall be initiated to ensure that the established mechanisms that must be initiated during true Product Recall are effective.
5.3
A senior person from QA department shall be nominated to have management responsibility for the administration of the Mock Recall.
5.4
Sufficient staff and appropriate priorities shall be assigned to allow the exercise to be conducted within one working day.
5.5
For the purpose of this Mock Recall exercise, the Head – QA shall select a specific batch of distributed finished product that shall be considered the subject of Recall.
5.6
Following points shall be referred for process of the Mock Recall.
5.6.1
For a finished product, the primary objective is to be identified.
5.6.2
The distribution history of that product batch or all batches of finished product in which the batch of active raw material used in the selected batch was used.
5.6.3
The confirmed location of the batch production and packaging records associated with the above batches.
5.6.4
The distribution history of batch or all batches of finished product in which that raw material lot was used.
5.6.5
The amount and location of any remaining in-house stock of finished product batches / raw material.
5.7
The following additional information must be confirmed on each occasion.
5.7.1
The current telephone and fax number of the Regulatory Agencies are available.
5.7.2
Current telephone numbers are available for all distributors / customers identified in the Mock Recall.
5.8
Only the procedures defined in SOP for Procedure for Product Recall must be used for this exercise.
5.9
The formal protocol and report of the Mock Recall must be produced by the Quality Assurance person, and together with all records must be maintained for a minimum period of five years. The report must identify any procedural weakness highlighted by the exercise, and make specific recommendations for their resolution.
5.10
It will be the responsibility of the Quality Assurance person to ensure that appropriate action is taken to implement those recommendations promptly to ensure that procedures are appropriate and up to date in the event of a true recall.
5.11
Mock Recall exercise shall be carried out annually.
5.12
An effort shall be made to close mock recall within time mentioned for the type of recall as per the “Procedure for Handling of Product Recall’’
5.13
Protocol & Report of Mock recall shall be numbered & same shall be entered in the numbering log.
6.0
Distribution :
6.1
This SOP (Controlled Copy) shall be distributed to Quality Assurance Department.
7.0
Annex(es) :
Template for mock recall Protocol.
Template for mock recall Report.
8.0
Reference(s) :
8.1
Nil
9.0
Abbreviations:
Nil
10.0
SOP Revision History Record :
Revision No. Details for Revision(s) with Change Control No. Effective Date (Sign. / Date)
