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Product Quality Reviews and Its Importance in Product Lifecycle

Muhammad Zubair*

Product Quality Review (PQR) is core function of Pharmaceutical Quality System (PQS). Purpose of this review is to verify the consistency of manufacturing process, verify the appropriateness of specifications for the testing and analysis of both starting materials and finished goods, highlight any adverse quality trends and identify any product and process improvement. As per current guidance the manufacturer has to perform these reviews annually and where small number (statistically invalid) number of batches is manufactured review may be extended up to 2 years. The contents of PQR shall be designed in such a way that these are able to capture product quality events and thoroughly document any potential impact on process or system as a whole that enables to investigate any event i.e. failure or rejection. In order to identify the trends in process an appropriate statistical method shall be used i.e., use of control charts, process capability and other related statistical tools. WHO, USFDA, TGA Australia, EU and PICS have issued specific guidelines regarding PQR and its content. More or less the requirement by all these bodies is same and focus is on continuous improvement of process and product quality throughout the product lifecycle.