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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.
21 May 2019 | By Dr Tony Cundell - Microbiological Consulting LLC
This article expresses the opinions of a pharmaceutical microbiologist on the proposed revisions to the EU Good Manufacturing Practice Annex 1 in terms of current industry practice and future innovation in sterile product manufacturing.
14 May 2019 | By Abbott Informatics
With international regulatory agencies calling for pharma companies to properly manage data integrity issues to ensure GMP compliance, Abbott Informatics demonstrates how their STARLIMS solutions can provide support for numerous systems.
25 April 2019 | By European Pharmaceutical Review
This issue questions whether companies are sufficiently investing in regulatory intelligence software and what the potential consequences of Brexit might be for locations outside of the UK and EU. The issue also features articles on microbiology, formulation and biopharma, courtesy of our in-depth focus sections; as well as outlining the…
18 April 2019 | By Biotechpharma
Biotechpharma UAB will expand its existing manufacturing facility by adding a new line of bioreactors
12 April 2019 | By European Pharmaceutical Review
FDA has launched a notification system where device manufacturers and users may notify the agency of any shortages or related supply issues stemming from sterilisation facility shutdowns...
21 February 2019 | By Telstar
The pharmaceutical industry is increasingly using different sterilisation technologies rather than steam sterilisation. This increase is driven by the need for sterilising thermo-labile products or areas that cannot be dimensioned as a pressure vessel (barrier systems such as Closed Restricted Access Areas or Isolators), under “softer” conditions.
20 February 2019 | By Eurofins CDMO
Eurofins CDMO provides a full suite of drug development services encompassing development of the bioprocesses, formulation screening, analytical development, pre-clinical testing, sterile and non-sterile bio-manufacturing of clinical trial batches and orphan drugs.
18 January 2019 | By Almac Group
The Almac Group, a CDMO serving the pharmaceutical and biotech sectors globally, is expanding its Edinburgh Technopole facility to allow scale-up of its personalised cancer vaccine activities...
12 December 2018 | By Thermo Fisher Scientific
The rapid increase in demand for biopharmaceuticals presents manufacturers with unique challenges to ensure quality and regulatory compliance while maintaining supply and production capacity.
6 December 2018 | By European Pharmaceutical Review
The US FDA has announced that it will confirm the capability of five more countries to carry out good manufacturing practice (GMP)...