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Survey of qualified persons on remote certification
Social distancing posed an interesting question for the Qualified Person (QP) in the early days of the COVID-19 pandemic: Is it permissible, or pra...
Techniques for conducting quality audits
Auditors should be direct and avoid asking questions to purposely try and stump the auditee. In addition, auditors should be instructive, explainin...
A global study of the performance of cleanroom garments over their life cycle
Sterile garments for cleanroom use often present a variable performance over their entire life cycle as they are vulnerable to damage from launderi...
COVID-19: remarkable progress with vaccines and therapeutics
The COVID-19 pandemic has resulted in an unprecedented amount of research to find suitable vaccines and treatments for this viral condition. This a...
Professor Luigi Martini joins EC as the Editor of the IP Journal
Professor Martini is Chief Scientist for the Royal Pharmaceutical Society (RPS) where he ensures that the RPS stays at the forefront of medicines d...
Dr Tim Sandle joins GMP Review as its new Editor.
Dr Tim Sandle is the new editor of our journal GMP Review and follows in the footsteps of previous distinguished editors John Dolman, Kate McCormic...
Getting started with FMD - A pharmacy perspective.
With the start of medicines pack authentification under the Falsified Medicines Directive (FMD) now in force, writing on behalf of the UK FMD Worki...
Regulatory inspections of sterile facilities – the focal points Part 1: Visual inspection of particulate matter
Sterile manufacturing is a continuum that stretches from development to manufacturing, to finished product; and to marketing and distribution, as ...
Risk and science-based validation of cleanroom garments
Important quality attributes of cleanroom garments that are worn during the manufacture of sterile medicines include; cleanliness, sterility, parti...
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