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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.
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...
29 January 2018 | By Tecan
Tecan’s range of advanced liquid handling solutions will soon be enhanced with the introduction of the new Fluent® Gx Automation Workstation*, designed specifically to meet the stringent needs of clinical and regulated laboratories...
10 January 2018 | By Watson-Marlow Fluid Technology Group
New from Watson-Marlow Fluid Technology Group (WMFTG) is the Flexicon PF7 peristaltic tabletop aseptic liquid filling machine optimised for operation in GMP regulated industries such as biotechnology, pharmaceutical and diagnostics...
22 August 2017 | By European Pharmaceutical Review
In this in-depth focus: Non-contact single cell adhesion and micromechanical property characterisation with ultrasound. Is high resolution mass spectrometry the missing piece in continuous bioproduction? Regulatory, clinical and logistics challenges of ATMPs in clinical research...
13 August 2017 | By European Pharmaceutical Review
Scale-up and manufacturing strategy for insect cell culture (ICC) should be assessed at the earliest stages of process development. Your final goals will shape the process and determine at what stage to implement steps that can make the process more reliable and robust at manufacturing scale. Sharyn Farnsworth, Associate Principal…
21 July 2017 | By Steve Bremer (European Pharmaceutical Review)
New ISPE guidance provides a scientific, risk-based approach for managing cross-contamination risk within shared facilities ...
28 June 2017 | By European Pharmaceutical Review
In Issue #3 2017: In-Depth Focuses covering Raman Spectroscopy, Separations & Purifications, Formulation Development & Delivery; Guide To Testing Services; GMP and mutual recognition; Regulatory Insight; RMMs; Microbiology Series; and much more...
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