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Tuesday, August 4, 2009

SOP ANNUAL PRODUCT REVIEW

SOP for Annual Product Quality Review 
Purpose: - This SOP gives the method of collecting data for Annual product review

Responsibility:- Q. A. Manager

Precautions: Not applicable

General Condition:
Annual Product review of a finished is prepared for all the batches manufactured in a year i.e. January month to December month.

Procedure:
1. Annual Product review will be prepared only for commercial batches.
2. Collect following information’s for preparation of Annual Product Review-
(i) Product name
(ii) Composition & changes, if any
(iii) Number of bathes manufactured
(iv) Quantity of Finished product manufactured
(v) Quantity of Finished product released
(vi) Any changes in mfg./filling/packing
(vii) Any major modification of machines
(viii) Any modification in area / environment
(ix) Trends of analytical parameters
(x) Any deviation in analytical method
(xi) Any OSS of laboratory results
(xii) Brief summary of complaints
(xiii) Summary of stability results if any
(xiv) Any changes in packaging components
(xv) % yield of all batches with a average (finished product)
3. Prepare the trend graphs for data of finished product results.
4. Annual Product Review will be finally approved by Q. A. Manager.
Acceptance Criteria:
All the quality parameters are addressed.

Frequency: Once in a year.

Format for Recording: Make a suitable format
Following are some of articles which;will be useful for you in further understanding of aspects of sterile dosage form manufacturing

Pharmaceutical Validation

Cleen Room Classification

Pharmaceutical Industry

Pharmaceutical Manufacturing

Clinical Trials

Media fill

Regulatory Affairs in Pharmaceutical Industry

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