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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.
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)...
26 November 2018 | By Eurofins
Companies often need to arrange for the synthesis of test substances to support research and development efforts.
26 November 2018 | By Eurofins
On 23 June 2016, the decision was made on the European Union referendum for the United Kingdom to withdraw from the European Union.
21 November 2018 | By BioSpectra
BioSpectra offers US based, custom GMP manufacturing of small molecules...
1 November 2018 | By KLK OLEO
KLK OLEO offers polysorbates, glycerine, MCT oils and more for pharmaceutical applications...
30 October 2018 | By Wickham Laboratories
Wickham Laboratories draws on deep technical expertise, backed by decades of global experience, when identifying challenges and providing solutions for a broad range of products and testing scenarios.
29 October 2018 | By Eurofins
Eurofins BioPharma Product Testing’s facilities deliver the world’s most comprehensive scope of harmonized GMP testing services and seamless regulatory acceptance.
26 October 2018 | By Charles River
Accugenix ® microbial identification and strain typing services, from Charles River, offer unparalleled accuracy in identifying microbes.
5 October 2018 | By PerkinElmer
The control of impurities plays a crucial role in Pharma QA/QC and can be divided in 3 main buckets: Organic, Inorganic and Residual Solvents. On this webinar we are focusing on analytical techniques used for control of Inorganic impurities and Residual Solvents...
14 September 2018 | By Mike Stones
The FDA is seeking closer collaboration with state authorities to ensure the quality of compounded drugs and the public’s access to them...
10 September 2018 | By Mike Stones
Improving data integrity is the aim of a new guide published by the Russian State Institute for Drugs and Good Practices in collaboration with consultancy PQE Group...
8 August 2018 | By SUEZ
The US FDA and European Commission have defined regulations relating to the submission of electronic records in lieu of paper documents, for submission, inspection, and archiving purposes. When ageing analytical equipment is to be replaced 21CFR Part 11 and EU Annex 11 are also topics of discussion. Common questions from…
19 July 2018 | By Mike Stones
The EU and Japan have agreed to widen the range of medicines for which they will recognise each other’s inspections of manufacturing sites.
9 February 2018 | By Kaiser Optical Systems
Regulatory guidelines, from the 2004 U.S. FDA PAT framework to ICH Q8, Q9, Q10 and Q11 documents, have brought a shift to pharmaceutical processes and manufacturing...
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