All GMP and quality management systems (QMS) articles – Page 7
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ArticleMedicinal cannabis: the route to good manufacturing practice registration
Following on from the first GMP registration of a cannabis API for a UK pharmaceutical facility, EPR spoke with Celadon Pharmaceuticals about how it navigated the complex regulatory landscape.
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Video
Video: Understanding current regulatory thinking on contamination control strategy
Virtual seminar presented by Ziva Abraham, President, and CEO of Microrite designed to improve your understanding on current regulatory thinking on designing an effective contamination control strategy.
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WhitepaperWhitepaper: Rapid adoption of medication adherence and smart packages – key factors driving interest and consideration
Read this whitepaper to understand the power of digital technologies in advancing medication adherence during clinical trials.
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NewsEMA publishes updated Q&A for ICH M10
An updated Q&A document for ICH M10 'Bioanalytical Method Validation and Study Sample Analysis’ has been published by the European Medicines Agency (EMA).
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NewsUK medical cannabis manufacturer granted GMP registration
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted a UK manufacturing facility good manufacturing practice (GMP) registration for its cannabis API.
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NewsSwitzerland and US sign drug inspection agreement
To promote Good Manufacturing Practice, Switzerland and the US have signed a Mutual Recognition Agreement to improve pharmaceutical drug inspection.
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Whitepaper
Case study: Expedite microbial contamination investigations
Find out how rapid microbial monitoring can help mitigate lengthy contamination investigations by identifying the root cause of high plate counts.
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Whitepaper
Whitepaper: Imaweld® heat sealable & weldable tube bioprocess media
Imaweld® is distinct due to its composition, which seals and welds tubes and highly endorsed in biopharma for cell membrane and cell culture applications