SOP for Product Traceability and Retrieval (Mock Recall)

OBJECTIVE

To define a procedure for initiating “Mocking Recall” of a product from the market & to able to track each lot of Raw, Packing material, and 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. The 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. The 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.

• The Warehouse Executive will get the information on the dispatches of required batches up to the stockiest level.
• All data of the “Mock Recall” system is to be sent to QA within 2 days of initiation.

ALSO READ: SOP for Handling of Deviation

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.

SUCCESS 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

ALSO READ: SOP for Product Recall