Finished Product Release

1.0  OBJECTIVE

To lay down a procedure for release of finished products.  

2.0 SCOPE

This procedure is applicable to Quality Assurance departments present in the XXX, Company. 

3.0 RESPONSIBILITY

3.1 Executive - IPQA

3.2 Head-Quality Assurance

4.0 PROCEDURE 

4.1 Dispatch of goods takes in two steps a) Transfer to Finished goods (FG) Warehouse b) Dispatch to the market from FG Stores.

4.2 Transfer to FG Warehouse: After reviewing the batch manufacturing record, Quality assurance shall permits the transfer of the packed batch to FG stores though Annexure-1 by signing on the stamp along with date” Transferred to FG Under Quarantine”.  The packed batches are held in the FG Warehouse in quarantine bay.  Clearly identified by pasting “Quarantined” label on the top of a single shipper on raised platform. The label format shall be as given in Annexure-2.

4.3 Dispatch of Finished Goods: After completing the analysis of finished product and on receipt of analytical report from Quality Control., the QA-Head issues finished product “QA Release” certificate (Annexure-3) to warehouse by verifying and signing on the batch record. On receipt of the QA release certificate the finished goods will be transferred to the Approved area after removing the Quarantine labels on the shippers. 

4.4 The batch records and data shall be reviewed for conformance with written procedures, operating parameters, and product specifications prior to arriving at the final release decision but not limited to the following

·Correct, approved, components are used in manufacturing

·Manufacturing control document is properly completed in all respects.

·Correct product is packed

·Correct packing components are used and the specimens of cartons, labels, leaflets, box labels & shipper labels etc are attached.

·Labelling bears the correct control number, expiry date.

·Yields and accountability are within action levels.

·Laboratory records are enclosed.

·Review of environmental monitoring reports: Results from microbiological monitoring should be reviewed and any unusual high counts should be investigated and risk to the product must be assessed before the batch is released.

·Review of filling Interventions.

·Review of environmental monitoring reports: Results from microbiological monitoring should be reviewed and any unusual high counts should be investigated and risk to the product must be assessed before the batch is released.           

4.5 Dispatch to Market: Finished goods shall be dispatched to Market after receiving the release slip from Head-Quality Assurance. Batches shall be released after review of BMR as per step No. 4.4 

5.0 ABBREVIATIONS

5.1 QA- Quality Assurance

5.2 BMR-Batch Manufacturing Record

6.0 ANNEXURE

6.1 Annexure -1: Finished Goods Transfer Note

6.2 Annexure -2: Quarantined label

6.3 Annexure -3: Finished Product QA Release