news
FDA steps up action to ensure quality of compound drugs
The FDA is seeking closer collaboration with state authorities to ensure the quality of compounded drugs and the public’s access to them...
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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.
news
Russian Institute for Drugs and Good Practices unveils new data guide
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...
webinar
Understanding current CFR 21.11 and data integrity requirements
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…
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EU and Japan extend partnership on inspections of medicine manufacturers
The EU and Japan have agreed to widen the range of medicines for which they will recognise each other’s inspections of manufacturing sites.
whitepaper
Application Note: Raman-based endpoint detection of a heterogeneous etherification reaction
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...
news
Tecan to launch Fluent® Gx Automation Workstation for use in regulated laboratories
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...
news
WMFTG unveils Flexicon PF7 tabletop peristaltic liquid filling machine
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...
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Biopharmaceutical Development & Processing In-Depth Focus 2017
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...
article
World-class CDMO: process development and GMP production baculovirus expertise
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…
news
ISPE updates guidance on risk-based manufacturing
New ISPE guidance provides a scientific, risk-based approach for managing cross-contamination risk within shared facilities ...
article
Issue #3 2017 – Digital version
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...
webinar
Understanding ISO Standards: ISO 14644-2:2015 Cleanroom Monitoring
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...
news
Wickham Labs to Exhibit at Pharmig 2016
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...
news
Wickham Laboratories Announces Renewal of FDA Accreditation
20 October 2016 | By Wickham Laboratories
Wickham Laboratories reports a successful completion of the FDA auditing process with renewal of GMP accreditation....
article
Managing contamination risks in glove holes in barrier separation technology
The manufacture of sterile medicinal and therapeutic products increasingly calls for aseptic processing using barrier separation technology comprising isolators and restricted access barrier systems (RABS) that have glove-sleeve systems.
