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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.
8 August 2018 | By SUEZ
Data integrity and 21 CFR Part 11/EU Annex 11 requirements are hot topics when ageing analytical equipment is to be replaced. Common questions from pharma and biopharmaceutical manufacturers include: is the new technology compliant with auditor expectations? Can we get the right data saved the right way in the right…
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...
19 January 2017 | By Particle Measuring Systems
ISO 14644-2:2015 is not only a new standard with which to be compliant, but is also a beneficial tool to use in achieving mature cleanroom environmental control. This webinar provides a review of the changes and how they affect your environment monitoring...
3 November 2016 | By Wickham Laboratories Limited
Wickham Laboratories will be on Stand 8 at the 24th Annual Pharmig Conference in the Nottingham Belfry Hotel, November 16th & 17th...
20 October 2016 | By Wickham Laboratories
Wickham Laboratories reports a successful completion of the FDA auditing process with renewal of GMP accreditation....
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