STANDARD OPERATING PROCEDURE APPROVAL OF FINISHED PRODUCTS

STANDARD OPERATING PROCEDURE

SUBJECT :                     APPROVAL OF FINISHED PRODUCTS

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

                                               

1.0       OBJECTIVE:

           

To provide guidelines for release of finished product.

2.0       SCOPE:

To give approval for dispatch after completion of analysis and checking of the packed consignment on finished product.

The Pack stock check record and Checklist for dispatch of finished goods is applicable for only DRL Products.

3.0       PROCEDURE:

3.1       After packing the product, executive QA will draw the samples at random intervals and will

             send to the laboratory. The packs will be stamped “Control sample Not for sale” and will be

            preserved in control sample room.  

3.2.      The Executive QA / Jr. Executive responsible for the sampling is witnessed by another QA

            Executive. The samples will be tested as per laid down specifications.

3.3.      The observations /calculations are entered in the Observation book and COA prepared.

3.4.      After the sample has been found passing as per the specification, APPROVED label are pasted on the Consignment in FG warehouse for all principal companies.

             For DRL products the FP report will be prepared in the product specified report format (SOP-10/QA, Annexure-1) and the report after completion will be checked against DRL specification for correctness. The checklist after review of analytical data (SOP10/QA, Annexure-6) will be filled and attached with the report.

3.5.     Pack stock check record Annexure-3 is to be updated online during packing and need to be

            attached in the Batch Manufacturing record after completion of packing. Pack stock check is

          done for DRL products only.

3.6      A pack stock verification of the packed goods is done before the release of the product.

3.7       The BPR and COA are reviewed after completing the packing activities & approved for dispatch, Approved label is pasted before the dispatch of consignment.

3.8      Checklist for dispatch of finished goods Annexure-4 is updated before dispatch and need to be attached in the Batch Manufacturing record after completion of Dispatch. Checklist for dispatch of Finished goods is shared to DRL QA along with the COA and is done for DRL products only.

4.0       FREQUENCY: As and when required.

5.0       RESPONSIBILITY: Production Executive / QA Executive.

6.0       REVIEW GUIDE:  Finished product COA and register.

7.0       ANNEXURE:             1. Finished product analytical report. (For DRL only).

2. Status labels.

3. Pack stock check record (For DRL only).

4. Checklist for Dispatch of Finished Goods (For DRL only).

5. FP report Format.

6. Check list after review of analytical data (For DRL only).

8.0       SOPs DISTRIBUTION:

            This SOP shall be distributed to following Departments:

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