SOP For Risk Management. Objective :- The purpose of this SOP is to lay out the procedure for Risk Management (risk identification, analysis, evaluation, reduction / mitigation, communication and conclusion of risk in order to ensure the quality, safety, integrity and purity of the drug product by using FMEA (Failure Mode Effect Analysis). Scope:- The […]
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Quality Risk Management In Pharmaceutical Industry. Quality risk management: A systematic process for the assessment, control, communication and review of risks to the quality of the drug (medicinal) product across the product lifecycle. Principles of Quality Risk Management Two primary principles of quality risk management are: The evaluation of the risk to quality should be
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