STANDARD OPERATING PROCEDURE ANNUAL PRODUCT REVIEW

STANDARD OPERATING PROCEDURE

                       

SUBJECT: ANNUAL PRODUCT REVIEW

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

1.0       OBJECTIVE:

The objective of Annual Product Review is to check the quality parameters of batches manufactured during the year and to outline a procedure for Annual Product Review.

2.0       POLICY:

It is for Wyeth & DRL policy to do Annual Product Review for all products manufactured during the year.

3.0       PROCEDURE:

3.1       After the completion of the year the product review is initiated by Executive-Q.A

3.2       A draft review report is prepared which has the following details.

3.2.1     Product Name

3.2.2     Table of contents

3.2.2    Batch Numbers manufactured during the year.

3.2.2    Review period.

3.2.2    Numbers of batches manufactured, Number of batches released & Number of Batches rejected.

3.3       The Annual product review includes the following parameters

3.3.1    Master formula and BMR review

3.3.2    Packing details of all the packs produced in the year. Price change if any and the lot number.

3.3.3    Approvals and Deviations.

3.3.4    R.M, P.M, In process and F.P Specifications review & Failure.

3.3.5    Investigations done during the year.

3.3.6    Complaints received & reviewed.

3.3.7    Yield data actual numbers and % yield, if out of limit reason.

3.3.8    Long range stability study done on selected batches stored at ambient conditions or conditions as specified on the label.

3.4       The data is tabulated.

3.5.      Graphic representation of the data is done.

3.6       The product review is sent to the principal for their review.

3.7       The product review is archived.

3.8       Review of microbiological results.

3.9       Review of water analysis

3.10     Trend analysis

3.11     Summary and recommendation if any.

3.12     The time limit for submitting Annual Product Review is within two months.

4.0       FREQUENCY:  Once Yearly.

5.0       RESPONSIBILITY:  G.M Q.A.

6.0       REVIEW GUIDE: Annual product review file.

7.0       ANNEXURE: 1. Annual Product Review.

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