Test to validate recall product

c.Planned activities to test and validate the recall procedure.

Validation of Recall procedure (SOP- Mock Recall) can be carried out as follows,
-Select any batch(es) of specific drug product which has been already distributed commercilally

  • Send communications to distributors, wholesalers, depots requesting them to send the information about units of that batch number which were sold and balance quantity remaining in their warehouse.
  • Now collect such information from all above stakeholders (they should send communication through emails to the company about units of that batch)
  • Reconcile the units (Manufactured & packed, Distributed, Sold out, and balance quantity in the warehouse).
    -Determine how many units can be recalled (if required to do so) from the above agents.
    -All above activities should be carried out in a time bound manner as per SOP on Mock Recall.
  • Determine efficiency of recall (Validation of Recall procedure).
    -Repeat this procedure at defined intervals for different products (preferably once in a year as per internal SOP).
  • Slection of products to be tested for recall should be done logically.
  • Entire recall activities should be documented in a report (Mock Recall report)
  • Recall activities should be co-ordinated by QA
    -This is not actual recall of a product, but it is a ‘Mock recall’ exercise to validate / verify effectiveness of the recall procedure (SOP) in a planned way.
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