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Pharmaceutical Manufacturing and Packing Sourcer

Digital World

The aim of regulatory standards is to minimise danger for patients and maximise product quality and safety through compliance. For instance, the EU’s EudraLex Volume 4 Good Manufacturing Practice (GMP) guidelines and the FDA’s 21 CFR Parts 210 and 211 describe the best production practices for medicinal products. Furthermore, EudraLex Annex 11 and 21 CFR Part 11 lay down the demands for computerised systems used as part of GMP-regulated activities. These systems are expected to be validated (the GMP-application) and respectively qualified (the GMP-IT infrastructure).

Official Industry Standards

How a pharmaceutical company goes about ensuring that the IT requirements for operational reliability, stability, business support and product quality are met is up to them, but major industry standards are pragmatic and can be used to conform to the law. Some of these are highlighted below:

GAMP 5
The International Society for Pharmaceutical Engineering’s Good Automated Manufacturing Practice (GAMP®) 5: A risk-based approach to compliant GxP computerised systems is the de facto voluntary standard for businesses active in regulated industries such as pharma, biotechnology, medical technology and their associated suppliers. GAMP 5 guidance provides a pragmatic and effective framework for achieving computerised systems that are fit for intended use and meet current requirements.

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Léon van Deurse is Senior Consultant at Chemgineering and has been working in IT for over 25 years. He has hands-on implementation experience with the top five ERP systems and how they can support business processes. As an IT Auditor, Léon has dealt intensively with financial IT audits of ERP systems. 
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Léon van Deurse
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