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
Biopharmaceuticals shall demonstrate at any time their compliance with Data Integrity (DI) requirements. We all know that data Integrity is not a new topic rather, it is an old concept made essential in today’s digital age.
I was asked one day to explain and to describe my professional job. Based on my educations, my skills and job experiences, I used to deal with quality and Good Manufacturing Practices (GMP) principles in Biopharmaceuticals, Foods, and cosmetics. I finally considered to qualified myself to improve human being by collaborating to deliver a quality