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Wyeth Pharmaceuticals - Articles and news items
The use of Process Analytical Technology (PAT) while a relatively new concept to the Pharmaceutical Industry has been a tried and tested concept in the petrochemical industry for many years. The adaptation of PAT systems by the Pharmaceutical Industry was accelerated by the recent initiatives of the regulatory authorities globally to modernize the Pharmaceutical Industry and focus on enhancing product quality. The common theme of the various initiatives is “planning for quality,” (i.e.) building quality into the products as compared to the traditional paradigm of testing the product to ensure quality.
In June 2006, the EMEA called for nominations from companies to participate in the pilot phase of a worksharing exercise for Quality variations1. Worksharing is a key element in the revisions to the variations proposed by the European Commission, which are intended to streamline the process for making changes to Marketing Authorisations, reducing the regulatory burden and encouraging innovation2. The worksharing procedure is intended where variations to the same nationally authorised product are submitted to the different National Competent Authorities (NCAs). All NCAs are eligible i.e. potentially all 29 EU/EEA states could be involved in the procedure.
ASTM Committee E55 formed in April of 2003 as a result of FDA’s GMPs for the 21st Century Initiative and the subsequent Guidance, “PAT – a framework for innovative pharmaceutical manufacturing and quality assurance.” Focusing on process understanding and flexible manufacturing, FDA encouraged the pharmaceutical industry to utilise the consensus standards approach to enable implementation of PAT principles into their manufacturing processes.
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