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The FDA\\\'s cGMP regulations require that an annual review (commonly called \\\

Conference on Annaul Product Quality Review


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About The Event

 Conference on Annaul Product Quality Review, 22nd December 2010, Hotel Kohinoor, Mumbai


The FDA's cGMP regulations require that an annual review (commonly called "Annual Product Review") be performed for all drug products and drug substances. The EU GMP regulations and also the ICH Q7A guideline for the GMPs for active pharmaceutical ingredients have corresponding detailed requirements. In each case, there is a general requirement that the quality of each product is reviewed at least once per year "to determine the need for changes in specifications or manufacturing or control procedures" and that any adverse or unexpected trends are identified so that corrective action can be taken. It is indicated that the review should encompass "a representative number of batches" and include considerations of "recalls," "product complaints", "returned & salvaged products" and "investigations" performed as a result of deviations encountered during production. The wording used is very broad and provides little guidance on what details should be addressed.

This article explains the need of conducting Annual Product Quality Reviews and sets out to describe a procedure for evaluation of data.

The Annual Product Quality Review (or APQR) has been a key component of cGMPs since their inception.  By formally collecting performance data for each product, we provide for a documented opportunity to ensure that the product continues to perform as designed.  The APQR can be utilized to encourage continuous improvement of the products being manufactured in a facility.  It is important to understand the APQR process and to demonstrate an approach for conducting an APQR that exhibits "best practices" and also provide an overview of commonly used tools to ensure that the review of APR data is statistically sounds and will reveal potentially adverse trends or negative signals. A complete example of an APQR will be presented.

The presentation will be the part of a case study of production batches and will walk through the analysis and assessment of these data for the APQR.  This will ultimately serve as a model APQR that could be adopted for use.

It also describe how the Lean or Six Sigma requirements of Chart and process capability index calculations can be effectively used to both satisfy cGMP expectations and effect continuous improvement of products and processes.

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