news
Automation to guide technology shift in aseptic environments
Referencing Annex 1–2022, a paper has described how automation will be implemented in aseptic environments in view of regulatory requirements.
List view / Grid view
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.
webinar
Route scouting for a cost-effective process development
26 May 2023 | By Thermo Fisher Scientific (Patheon)
Watch this webinar to discover how route scouting and polymorph screening at early stages of clinical trials can support scale up to commercial manufacturing.
whitepaper
Press release: SGS launches SGS PACE, a streamlined pathway through preclinical, formulation, FIH and POC
SGS PACE is a seamless combination of world-leading development, bioanalysis and clinical research through one point of contact.
whitepaper
Press release: Biopharmaceutical testing capabilities increasing in Switzerland
SGS have relocated their biopharmaceutical testing laboratory in Plan-les-Ouates, Switzerland.
whitepaper
Product hub: GMP ready: Ultrapure water, passcode access, validation support and TOC verification
Reliable, intuitive and simple to use. Bringing ELGA's ultrapure water purification to GxP Quality Control Laboratories.
whitepaper
Product hub: How can aseptic manufacturers prevent losses in the millions?
Highest precision with microbial air sampler MAS-100 Iso. So you can focus on the essential.
whitepaper
Brochure: The Caliber Manufacturing Suite – CaliberBRM
CaliberBRM is a manufacturing product suite that digitalises and automates pharmaceutical manufacturing processes for a paperless, future-ready lab.
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.
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.
