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Pharmaceutical Manufacturing and Packing Sourcer
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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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News and Press Releases |
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Saneca Pharma strengthens senior team
Slovakia-based CDMO adds senior talent to its team to position the
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White Papers |
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Clinical Trials in Russia Orange Paper: 2nd Quarter 2014
Synergy Research Group
The Ministry of Health of Russian Federation approved 194 new clinical
trials of all types including local and bioequivalence studies during
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The main contribution to the total number of studies was
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Industry Events |
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BIO-Europe® 2017
6-8 November 2017, Messedamm 26 14055 Berlin Germany
The 23rd annual BIO-Europe® event is the largest biotechnology partnering conference held in Europe. Over 3,800 global decision makers from biotechnology, pharma and finance annually attend BIO-Europe to identify new business opportunities and develop strategic relationships. Business development executives and dealmakers consider BIO-Europe a must-attend event and an effective business strategy enabling them to meet and present to numerous potential partners. BIO-Europe features the industry’s most advanced web-based partnering system enabling delegates from all parts of the biotechnology value chain to quickly identify, engage and enter into strategic relationships that drive their business successfully forward.
BIO-Europe's world-class workshops, panels and active exhibition along with thousands of prescheduled one-to-one meetings make this event an unrivaled forum for companies across the biotech value chain to meet and do business.
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