Recall and Mock Recall

Quality Assurance
1

What are the main difference between Recall and mock recall of finished goods?

Thanks

2

A Recall of a product means actually withdrawal of the specific batch (s) of that product from the market in order to prevent it’s consumption by the patients. There could be various reasons for eecall such as quality defect, Serious asverse reactions, poor packaging, or as directed by the Regulatory Authorities. Based on the severity of the problem associated with the product, the duration of Recall can vary from say 24 hours to a week or so.

On the other hand, Mock Recall means it is a planned exercise conducted by pharmaceutical company in co-ordination with QA, Sales and Warehousing teams of that company. In this process, batch (s) of specific product (s) are randomly selected which were already sold in the market. It’s distribution system is taken in to consideration and and how effectively it could be recalled is studied through review of records, documentation and readiness of the entire distribution system to take back the product within defined time duration. Therefore, it’s effectiveness is determined by traceability / distribution status of the specific product batches selected, contacting wholesalers and retailers, Hospitals, pharmacies to whom the batches were distributed, quantities of those batches sold and unsold at each level of distribution, review of transportation system, and distribution records maintained in the Finished goods warehouses etc.
Mock Recall is a paper work (documentation) and review of entire distribution system with respect to selected batches of specific product within defined time interval. Reconciliation of the units of selected Batch(s) is very important aspect. After completion of activities a full Mock Recall report should be written and maintained.
Mock Recall should be conducted periodically, at least once in a year to ensure effectiveness of the entire Recall system in a pharmaceutical company. It is a mandatory requirement.

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3

Mock recall is just copy of actual procedures to check the system alertness n responces.
Physically no product is withdrawn from market.
In recall prduct is phsically withdrawn from market.

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4

Yes, it is. the same as l explained.

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5

Thank you your detailed answer. I wonder if there is any guidelines explaing regularly aspects in this regard?

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6

Thanks…
Guidelines explain the requirement and frequency of conducting mock Recall. Considering the objective behind mock Recall the pharmaceutical company has to design suitable procedure to conduct this exercise at defined frequency. There has to be internal SOP to follow this.

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