STANDARD OPERATING PROCEDURE FOR PRODUCT APPROVAL AND RELEASE OF PRODUCT

1.0 OBJECTIVE

To lay down the procedure for approval and release of the finished product. The solution consists of verifying the product’s compliance with the requirements of applicable standards and technical regulations following a review by product specialists, of reports from verification activities such as laboratory testing, physical inspection, and factory audits. Conformity of products is evidenced by the issuance of a Certificate of Conformity (CoC), a document that is mandatory for customs clearance.

2.0 SCOPE

This SOP shall be applicable for approval and release of the finished product.

3.0 RESPONSIBILITY

3.1 QC Inspector is responsible for the preparation of this SOP.

3.2 Chemist and above designee shall be responsible for the execution of this SOP.

3.3 Manager QC and Manager QA shall be responsible for checking and approval this SOP.

3.4 HOD shall be responsible for authorization of this SOP.

4.0 ACCOUNTABILITY

Head Quality Control Department

5.0 PROCEDURE

5.1 Finished samples from/ manufacturing area should be analyzed as per the procedure under Standard Test Procedure/ Pharmacopoeia standard.

5.2 For other finished product analysis, persons from the production department should fill the sample intimation request and forward it to IPQA for sampling and the sample will be given to Quality Control along with the sample intimation request.

5.3 After sampling enter the record.

5.4 QC head should assign the work to chemist/ supervisor and inform the results complies/ does not comply with concerned production department on completion of analysis through QA head.

5.5 After completion of the testing record the results and report should be made.

6.0 REFERENCES

N.A

7.0 ANNEXURE

Annexure No.	Title of Annexure	Format No.
Annexure-I	Product  Release  Certificate  For  Dispatch	F………………………….

8.0 ABBREVIATIONS

SOP : Standard Operating Procedure

QCD : Quality Control Department

QA : Quality Assurance

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