What is Recall of Product :
A product recall is a request from a manufacturer to return or removal of a marketed product after the discovery of safety issues or product defects that might endanger the consumer or put the maker/seller/ manufacturer at risk of legal action.
The manufacturer not only has to pay the cost of replacing & fixing of defective products but also it will down the image of Organization.
There are different types of recall i.e. Class I, Class II & Class III.
Class I :
A Recall situation in which there is a reasonable probability that the use of, or exposure to, a defective product is life threatening or could cause serious risk to health or death. Recall and procedure to be initiated within 24 hrs.
Class II :
A Recall situation in which the use of, or exposure to, a defective product could cause illness or mistreatment but is not Class- I. Recall and procedure to be initiated within 48 hrs.
Class III :
A Recall situation in which the use of, or exposure to, a defective product is not Class – I or Class – II and may not pose a significant hazard to health, but withdrawal may have been initiated for other reasons.
To be recalled after hearing and answering show cause notice.
How to Conduct recall :
1.The manufacturer regulatory agencies shall get notification regarding the recall
2. The product to be recalled is in the hands of consumers, through different medium like a press release or Electronic media .
3. The Product Recall form shall clearly mention the levels up to which (distribution / patient / depot) the recall effects shall be executed.
4. All the requirements of country specific Regulatory Authorities shall be completed jointly by manufacturer and agent as a distributor.
5. Recall status report shall be provided to the Regulatory Agency
6. All the stocks returned from distribution should be sent by the market support services to the plant warehouse under intimation to the Regulatory Affairs department and location QA The location QA must reconcile the recalled stock .
7. The recalled goods and other inventory of the same batch or product in quarantine and shall be stored in a segregated area to avoid Mix-up with the other products.
8. The Recall will be closed (notifying the Regulatory Agency that Recall is considered closed) and the contract companies or distributors shall be notified via mail when the regulatory agency acknowledges the termination of Recall.
9. Efforts shall be made to close the recall procedure & A final status report and documentation of recalled product disposition should be provided to the Regulatory Agency.
10. The customer will get their refund depends upon the condition of the product.
11. The compensation may vary depends on the law of the particular country.
What is the meaning of Mock :
Make a Duplicate or exact copy of something
What is Mock recall :
Mock recalls are routine exercises conducted by manufacturers, processors, distributors and other various trading partners in the supply chain to assess or verify their recall procedures and responsiveness and to train the recall team.
Mock recall has to confirm the efficient collation of batch history details and effectiveness of communication channels.
How to Conduct Mock Recall :
- Initiation of Mock Recall activity by the Manufacturer & select one batch which was distributed to the market .
- QA forward details of Product name with batch number to warehouse for the entire dispatch details
- Communication to Customer/Client for the execution of Mock recall
- QA forward details to Marketing for the Confirmation of Dispatch details
- Communication to Qualified person/Customer for the execution of Mock recall
- QA forward details to Marketing for the confirmation of dispatch details
- Marketing provide the details of the Distribution/Shipment
- Marketing Authorization Holder /Qualified Product Conduct Mock recall & Marketing Authorization Holder / Qualified person provides information to its warehouse/depot
- Reconciliation of Data at Qualified Person end & Qualified person shall mail receipt Data to QA Head.
- Reconciliation of Data from Manufacturer end & if found Satisfactory Reconciliation then Closure of Mock recall.
The following information must be confirmed after Mock Recall :
|1. The current telephone and fax number of the Regulatory Agencies are available.|
|2. Current telephone numbers are available for all distributors/customers identified in the Mock Recall.|
|3. Procedure for Product Recall must be used for this exercise.|
|4. The report must identify any procedural weakness highlighted by the exercise, and make specific recommendations for their resolution.|
|5. It will be the responsibility of the Manufacturer 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.|
A mock recall simulation is one of the best ways to test your recall plan and allows you to identify holes in your plan before it’s too late. It can also save your organization from wasting resources when a recall is necessary. Mock Recall exercise shall be carried out Yearly basis. Not only for Pharma but also for other industry like food, motor, beverage etc. Mock Recall is applicable.