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

2020-08-11T09:12:12+00:00July 7th, 2020|

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 [...]

Good weighing practice (GWP) for laboratory and production balances

2020-08-11T09:13:05+00:00July 7th, 2020|

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 [...]

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

2020-08-11T09:13:45+00:00July 7th, 2020|

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 [...]

Validation- What is it?

2020-08-30T09:10:19+00:00January 27th, 2016|

What is Validation? Validation is documented evidence that demonstrates a process/equipment/system/software/procedure which complies with specifications, criteria and requirements defined in a pre- approved protocol and detailed in: Specifications Definitions [...]

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