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Tag: QRM

Posted on August 17, 2023
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Posted in Regulatory Affairs, Quality & Compliance
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Leave a Comment on Keeping health product safe in Canada

Keeping health product safe in Canada

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

Tagged : Compliance, Health Product, QRM, Regulatory, Risk Management

Posted on December 20, 2022
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Posted in General
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Leave a Comment on Quality Risk Management in Pharma

By - Kossi Molley (he/il)

Quality Risk Management in Pharma

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

Tagged : CQA, GxP, QRM, Risk Management