Procedure for Handling of Mock Recall

1.0Objective :
 To lay down the procedure for conducting Mock Recall.
2.0Scope :
 Scope of this document is to follow procedure for Mock Recall.
3.0Responsibility :
3.1Quality Assurance Department for conducting, monitoring and administration of Mock Recall procedure.
4.0Definition(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.
5.0Procedure :
5.1No contact shall be made with customers, contract clients & Regulatory Agencies, unless specifically authorized by Head – QA.
5.2Upon 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.
5.3A senior person from QA department shall be nominated to have management responsibility for the administration of the Mock Recall.
5.4Sufficient staff and appropriate priorities shall be assigned to allow the exercise to be conducted within one working day.
5.5For 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.
5.6Following points shall be referred for process of the Mock Recall.
5.6.1For a finished product, the primary objective is to be identified.
5.6.2The 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.
5.6.3The confirmed location of the batch production and packaging records associated with the above batches.
5.6.4The distribution history of batch or all batches of finished product in which that raw material lot was used.
5.6.5The amount and location of any remaining in-house stock of finished product batches / raw material.
  5.7The following additional information must be confirmed on each occasion.
5.7.1The current telephone and fax number of the Regulatory Agencies are available.
5.7.2Current telephone numbers are available for all distributors / customers identified in the Mock Recall.
5.8Only the procedures defined in SOP for Procedure for Product Recall must be used for this exercise.
5.9The 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.
5.10It 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.
5.11Mock Recall exercise shall be carried out annually.
5.12An 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’’
 5.13Protocol & Report of Mock recall shall be numbered & same shall be entered in the numbering log.
6.0Distribution :
6.1This SOP (Controlled Copy) shall be distributed to Quality Assurance Department.
7.0Annex(es) :   
 Template for mock recall Protocol.
   Template for mock recall Report.
8.0 Reference(s) :
9.0             Abbreviations:
10.0SOP Revision History Record :
   Revision No. Details for Revision(s) with Change Control No. Effective Date (Sign. / Date)

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