תעשיות ביו-טק ופארמה

Background and history The FDA (US Food and Drug Administration) was established in 1901 as a bureau of the Chemistry Division of the Department of Agriculture. Five years later, Read More >>>

1. Background Many biopharmaceutical and biological products are based on (different) cell-type fermentation. Biopharmaceutical products can be either intracellular or extracellular metabolites that have a pharmacological effect. Fermentation, as Read More >>>

1. Introduction "Non-conformity" investigation is very common term being used in production and product quality improvement areas in the Pharmaceutical and Medical Devices world. It is mandatory and considered as Read More >>>

1.  What is software validation? Software Validation is part of the computerized system validation (CSV) process. Computerized system validation defined as a documented evidence with a high degree of assurance Read More >>>

1. Introduction Weighing raw materials, product, reagents, excipients and other product related materials is a risk procedure in the Biotechnology and Pharmaceutical areas. Any weighing mistake in case not detected Read More >>>

1.     Background Good Storage and Distribution Practice (GSP/GDP) describes human, veterinary and investigational drug substance and drug products supply chain procedures and standards in order to assure the Read More >>>

1.  Background The usage of stem cells for therapeutic and clinical applications is a fast growing area in Biotech research and development. Stem cells potential to differentiate into specific cells Read More >>>

1.   Background and history The FDA (U.S Food & Drug Administration) was established in 1901 as a bureau of the Chemistry Department of Agriculture. Five years later, a regulatory function Read More >>>

1. Background Many Bio-Pharmaceutical and biological products are based on (different) cell-type fermentation. Bio-Pharmaceutical products can be either intra or extra cellular metabolites that have a pharmacological effect. Fermentation, as Read More >>>