RABS are a type of barrier system that separates the production area from the operator environment by using a rigid machine enclosure, safety-locked doors and ports with gloves.
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The field of biomanufacturing is undergoing a remarkable transformation with the integration of Artificial Intelligence (AI) technologies. AI, a domain of computer science that aims to create machines capable of intelligent behavior, is revolutionizing the way biopharmaceuticals and other bioproducts are developed, manufactured, and refined.
Keeping health products safe means ensuring that the product lifecycle are implemented and in control. The health product lifecycle here refers to all stages in the pre- and post-market “life” of a health product. According to Health Canada, the stages may include several or all of the following: pre-clinical studies, clinical trials, submission of product
As per Health Canada Guidance on GMP, GUI-0001, Quality risk management is a systematic process for the assessment, control, communication and review of risks to the quality of a drug across the product lifecycle [1]. In other words, the risk Management is defined as the identification, analysis, assessment, control, and avoidance, minimization, or elimination of unacceptable risks
Because of pandemic situation and the Russia-Ukraine war, Organizations have opportunities now to try new methodologies that will help them to be more efficient and successful in the long run. One thing among others you can do is to control your losses by implementing OEE tool. What is OEE The Overall Equipment Effectiveness (OEE) of