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.