A warning has been issued to Stemell for manufacturing and distributing unapproved products derived from umbilical cord blood.
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Good Manufacturing Practice (GMP)
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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.
This application brief presents a framework for how to establish acceptance criteria limits using TOC to comply with FDA best practice guidance for the life cycle approach to cleaning validation.
Expert View: Annex 1 updates: The impact of microbial ID strategy on cleanroom qualifications for pharma manufacturers
Dr Lucia Ceresa discusses the importance of accurate microbial IDs for cleanroom performance qualification and the risks of inaccuracies or failures.
Ningbo Huize Commodity Co has been sent a warning letter for cGMP violations, including data integrity issues.
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.
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…
Biotechpharma UAB will expand its existing manufacturing facility by adding a new line of bioreactors
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...
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.