STANDARD OPERATING PROCEDURE PRODUCT TRACEBILITY & RETRIEVAL (MOCK RECALL)

STANDARD OPERATING PROCEDURE

SUBJECT :                     PRODUCT  TRACEBILITY & RETRIEVAL (MOCK RECALL)

DEPARTMENT           : QA SOP NO.                      : Page No                       : Effective Date             :   Next Review                :           :

1.0       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.

2.0       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.

3.0       PROCEDURE:

3.1       Q.A initiator to consider any active ingredient /batch manufactured for recall.

3.2       Production / Ware house 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 stockist level.

3.3       All data of “Mock Recall” system is to be sent to Q.A within 2 days of initiation.

3.4       REFERENCE DOCUMENTS

3.4.1    BPR, PDR analytical reports RM, Finished & Packing material.

3.4.2    Warehouse- FSRN/STN.

3.4.3    Logistics- Invoices of all dispatches with quantity/location of the batches under consideration.

3.5       SUCESS CRITERIA

3.5.1    Distribution records must permit a customer {stockist} 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 stockist.

4.0      FREQUENCY: As and when required.

5.0       RESPONSIBILITY: G.M (Q.A).

1.0        REVIEW GUIDE: Mock recall records

7.0       ANNEXURE: -------

8.0       SOPs DISTRIBUTION:

            This SOP shall be distributed to following Departments:

Name of the Department	Master Copy	Circulatory Copy
QA/QC	√	√
Production	x	x
Warehouse	x	x
General	x	x
Maintenance	x	x