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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 [...]

New drug development and regulation from clinical trials to marketing approval

2020-08-16T12:54:06+00:00June 18th, 2020|

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 [...]

Medical device cleaning techniques and validation

2020-08-30T12:44:07+00:00June 18th, 2020|

The purpose of medical device cleaning validation is to assure that the medical device cleaning procedure consistently controls potential carryover, contaminants, cleaning agents and extraneous material into the [...]

Risk Assessment and Risk Management in the Medical and Pharmaceutical Industries

2020-09-21T08:16:28+00:00June 17th, 2020|

The medical and pharmaceutical industries are involved in new product development and manufacturing of medicines, medicinal products, biological products, medical devices and combination products. Risk management is a [...]

Pharmaceutical and drug product registration and submissions in Israel

2020-08-30T11:01:38+00:00March 18th, 2019|

The process of pharmaceutical and drug product registration in Israel The main regulatory body for pharmaceutical administration in Israel is the Registration Department of the Ministry of Health [...]

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