whitepaper
Whitepaper: Designing an environmental monitoring solution for GMP
A review of current environmental monitoring practices to ensure that monitoring systems comply with the latest EU GMP Annex 1 2022.
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Good Manufacturing Practice (GMP)
Good manufacturing practices (GMP) are the practices required in order to conform to the guidelines recommended by agencies that control authorisation and licensing for manufacture and sale of drug products and active pharmaceutical products. These guidelines provide minimum requirements that a pharmaceutical manufacturer must meet to assure that the products are of high quality and do not pose any risk to the consumer or public.
article
Medicinal 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.
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.
whitepaper
Whitepaper: 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.
news
EMA 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).
news
UK 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.
news
Switzerland 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.
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.
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
webinar
Implementing a real-time PCR-based method for sterility release testing of ATMPs
23 December 2022 | By Sartorius
Dr Alexandra Mueller-Scholz, Sartorius, and Yasmin Heynen, Molecular Development at Labor LS, discuss rapid sterility testing for ATMPs using a real-time PCR-based method.
whitepaper
Whitepaper: Optimising the efficiency of QC laboratory: The power of automation
Charles River launches Endosafe Nexus 200, emphasises the importance of automated endotoxin testing systems to improve the efficiency of QC labs.
article
Whole genome sequencing and analysis of live biotherapeutic products
Here, Snehit Satish Mhatre and Michael Timm of Eurofins discuss considerations and recommendations for the testing of live biotherapeutic products.
whitepaper
Whitepaper: Single-use technologies in biosimilar development
ImaLINK™ manifold, which is designed to minimise the need for fittings, connections or assembly of all leak points, entrapment areas are eliminated.
article
The lingering menace of diethylene glycol / ethylene glycol adulteration
Although it was first identified in the 1930s, diethylene and ethylene glycol contamination remains an issue today, as Dave Elder explains.
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European Pharmaceutical Review Issue 6 2022
This issue includes articles on Raman mapping of pharmaceutical tablets, delivery options for mRNA therapeutics, the use of high-throughput analytics for clonal cell selection and much more...
