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 .
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Validation Master Plan is an approved written plan of objectives and actions stating how and when a company will achieve compliance with the GMP requirements regarding validation. It is a document which defines the intentions and the methods that are related with validation of facilities, utilities, system, equipment, instruments, materials, analytical methods, It Systems, cleaning procedures and processes.
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