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