Introduction "Nonconformity" investigation is a very common term used in production and product quality improvement areas in the pharmaceutical and medical devices industries. It is mandatory and a [...]
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 [...]
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 [...]
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 [...]
Background The use of stem cells for therapeutic and clinical applications is a fast growing area in Biotech research and development. Stem cells have the potential to differentiate [...]
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 [...]
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 [...]
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 [...]
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 [...]
