Qualification of pharmaceutical plants

Practical aspects of reporting, master plan and risk analysis

For manufacturers of pharmaceutical products, the performance of equipment qualification is an elementary component of the quality management system and a prerequisite for obtaining and maintaining manufacturing authorization.
According to the definition of the EU GMP regulations, the manufacturer of pharmaceutical products proves with the qualification of his equipment that it is suitable for the intended purpose. (Article in German language)

• authors: Jens Lehmann, Wolfgang Röper, Glatt Ingenieurtechnik GmbH
• originally published in the magazine ‘CHEManager’, issue 3-4 2012, Wiley-VCH Verlag GmbH & Co. KGaA