Pharma/BioTech industry2020-06-02T10:29:43+00:00

CE Annex 11, FDA 21 CFR Part 11: Computerized systems and software validation

What is software validation? Software validation is part of the computerized systems validation (CSV) process. Computerized systems validation is defined as documented evidence with a high degree of assurance [...]

Good weighing practice (GWP) for laboratory and production balances

Introduction Weighing of raw materials, products, reagents, excipients and other product related materials is an area which has risks in the biotechnology and pharmaceutical industries. Any weighing mistake which [...]

Good Storage and Distribution Practice (GSP/GDP), cold chain safety and validation

Background Good Storage Practice (GSP) and Good Distribution Practice (GDP) describe human, veterinary and investigational drug substance and drug product supply chain procedures and standards for assurance of the [...]

New drug development and regulation from clinical trials to marketing approval

Background After a new investigational drug pre-clinical stage 1 is completed, and a US IND (Investigational New Drug application) or EU CTA (Clinical Trial Application) submission to the FDA [...]

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