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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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Luina Bio Announces New Bio-Manufacturing GMP And Development Facility Expansion
1st September 2020
Highlights
• Small scale GMP manufacturing suites open in Q3 2020
• 500L tech transfer and process development site aim for open Q4 2020
• This precedes the next phase with Luina planning to commission a 10,000m2 late phase clinical and commercial production facility targeting late 2021
• New facilities capture more of the global value chain supporting technically advanced microbiome projects
• New expanded capacity for bacterial and yeast recombinant projects including vaccine manufacturing including COVID-19 candidates
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