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 product safe means needs to ensure 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
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 . In other words, the risk Management is defined as the identification, analysis, assessment, control, and avoidance, minimization, or elimination of unacceptable risks