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SOP for Product Traceability & Retrieval (Mock Recall)

OBJECTIVE
To define a procedure for initiating “Mocking Recall” of a product from the market & to in able to track each lot of Raw, Packing material & Finished products from suppliers to customers level.

POLICY
  • This system will trace the origin of the product right from the Raw material stage, till the Finished goods level at the stockiest and vice versa. Aim is to keep a clean check on our batch control procedures as per GMP. 
  • This is necessary so that proper action can be taken in the event of a quality problem at any step during the shelf life of the product. System must be tested at least annually with a “Mock Retrieval” which is reported and retained.

PROCEDURE
  • Q.A initiator to consider any active ingredient / batch manufactured for recall.
  • Production / Warehouse Executive will have photocopies of all the relevant supporting documents from the receipt and dispatches for finished goods / Raw material/Packing material.
  • Warehouse Executive will get the information on the dispatches of required batches up to stockiest level.
  • All data of “Mock Recall” system is to be sent to Q.A within 2 days of initiation.

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REFERENCE DOCUMENTS
BPR, PDR analytical reports RM, Finished & Packing material.
Warehouse- FSRN/STN.
Logistics- Invoices of all dispatches with quantity/location of the batches under consideration.

SUCESS CRITERIA
Distribution records must permit a customer {stockiest} list to be developed within two working days. Records must be accurate enough so that lot accounting is 98% complete up to the point of shipment to the stockiest.

FREQUENCY
As and when required.

RESPONSIBILITY
Quality Assurance
Warehouse

REVIEW GUIDE
Mock recall records

ANNEXURE
Nil

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