| 1.0 | Objective : |
| | 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. |
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