Abstract
A comprehensively designed Pharmaceutical Quality System (PQS) incorporating Good Manufacturing Practice and Quality Risk Management implemented, maintained and continuously improved, allows a consistent delivery of products with appropriate quality attributes. The manufacturer in the third country and the batch certification and release site in EU belong to the same organization operating under a corporate Pharmaceutical Quality System. A signed Quality Agreement between both parties provides improvement of the Pharmaceutical Quality System and continual maintenance of the quality of the medicinal product throughout its shelf life. This paper outlines the role and the challenges of the manufacturing site in third country within the process of batch certification and release in EU (by EU QP) and also highlights the importance of the technically justified approach including Quality Risk Management process regarding sampling in third country. Through a Technical justification for sampling including Quality Risk Assessment, it is considered that the samples taken from the manufacturing site in third country ensure representation of the whole batch. Technical justification is performed periodically to identify and manage any risks associated with this approach, thus ensuring the quality, safety and efficacy according Marketing Authorization. Keywords: batch release in EU, third country, Pharmaceutical Quality System, QP
Highlights
Pharmaceutical Quality SystemPharmaceutical Quality System, PQS incorporating Good Manufacturing Practice, GMP (Eudralex, Vol.4, Chapter 1) and Quality Risk Management, QRM (ICH Q9) is the basic concept for implementing consistent quality of pharmaceutical products
Manufacturing site and Batch certification and release site shall be responsible for transfer of testing method, using transfer protocols prepared by manufacturing site, approved by both parties
Risk acceptance and proposed further actions The risk should be accepted if the following conditions are met: - No risk for the product quality nor for the patient is found nor expected. - Regular audit at the manufacturing site, reviews and updates of all relevant Quality Agreements should be provided. - Continual monitoring of the process by batch certification and release site should be performed. - Imported product will be comparatively tested according to the risk-based approach to justify ongoing reliance on samples taken in third country - Plan for random periodic analysis of samples taken after importation to justify on going reliance on samples taken in a third country should be in place
Summary
Pharmaceutical Quality System, PQS incorporating Good Manufacturing Practice, GMP (Eudralex, Vol., Chapter 1) and Quality Risk Management, QRM (ICH Q9) is the basic concept for implementing consistent quality of pharmaceutical products. Continuously provides products with the highest standards for quality, safety and efficacy, fit for their intended use and fulfill the requirements of the patients, all relevant regulatory requirements and the requirements of the international standards (Directive 2001/83/EC; Directive 2003/94/EC). It is complex system, represented as the sum of all processes that are responsible for assuring quality of product.
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