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Friday, July 10, 2009

Annual Product Quality Reviews APQR in pharmaceuticals

Annual Product Quality Review

FDA in USA and around the world as well as c GMP guidelines, WHO gmp regulations directs that a pharmaceutical manufacturing firm should perform an annual product quality review commonly called Annual Product Quality Reviews for all pharmaceutical products manufactured by them and for all nuber of batches manufactured for the perticular year of review.

EU GMP guidelines as well as ICH Q7A guideline for the GMP for active pharmaceutical ingredients asks for respective detailed requirements.

Each Pharmaceutical Product and its quality should be reviewed once every year.

Annual product quality reviews helps in identifying areas of correction where one can do improvements

Annual product quality reviews helps to ascertain the integrity of quality of product and the process and controlls, it helps in further improvement of quality of pharmaceutical product manufactured in a firm.


Annual product quality reviews APQR should also recommend any changes if required so as to improve the quality of product.

1.Any changes in specifications of raw material, packing material, finished products.

2.It should also recommend any changes if required in any SOPS so as to improve the quality of product.

3.Manufacturing procedure and quality control procedures in process Quality controls.


Annual product review should provide a trend analysis of quality parameters such as ASSAY of active ingredients or In process controlls ,Quality Asurance report of the batch , impurities data in finished product or of any Active Raw Material used (example data of free salicylic acid in raw material Aspirin combined together in its starting Raw material used as well as in the final finished product), with its statistical presentation of such data and any trends which are adverse or unexpected.


APQR should also mention how these are identified and what corrective action is taken


All batches of pharmaceuticals in the perticular year shuld be included in the Annual product review report . APQR should be done on , all products , all batches .

It should include details of all recalls
It should include all details in batches reveiw which has any complaints all batches with deviations encountered during production
It should include details of all returned and salvaged products batches with complete investigations


With a due report on how these deviation or complaints or product discrepancies or quality complaints can be reduced or minimized or these complaints will not come in future, a action plan and its implementation in details.

Here you can find a sample document of Annual Product Review of a pharmaceuticals dosage form
Here you will find a SOP for Annual product quality reveiw
You can find on this blog about following topics and almost every topic on pharmaceuticals on this blog.
gmp guidelines for pharmaceuticals
cleaning validation in pharmaceuticals manufacturing
Process Validations in Pharmaceuticals
Find it here

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