whitepaper
Whitepaper: EPIQ – Solution Brief
EPIQ is a single platform for Quality, Document, and Learning Management. It offers integration across departments for a seamless quality management.
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.
video
Video: The EU Annex 1 Good Manufacturing Process (GMP) updated requirements
How the GMP requirements affect the manufacturing of sterile medicinal products from European Member States and products imported from outside Europe.
video
Video: An introduction to Protak Scientific and Enzyme Indicators for advanced, gaseous bio-decontamination validation
The advanced rapid validation tool for measuring hydrogen peroxide bio-decontamination performance that’s transforming the validation process in pharmaceutical manufacturing and other applications including healthcare and research.
whitepaper
Case study: Eliminating contamination with whole genome sequencing
Read this case study to learn how a pharmaceutical company used Accugenix Whole Genome Sequencing for bacterial and fungal ID.
whitepaper
Scientific journal: Reduce CNS drug development timelines by up to 40%
CNS drug development is complex, and partnering with an integrated CRO/CDMO can reduce your timelines by up to 40%. Learn more in The Altascientist.
news
Radiopharma production facility opens in Belgium
Australian biotech Telix Pharmaceuticals has unveiled a new €14.1 million radiopharmaceutical production facility in Brussels South, Belgium.
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.
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.
