Application Of Ich Q9 As A Systemic Process For The...

Introduction ICH Q9 (Quality Risk Management-QRM) is a systemic process for the assessment, control, communication and risk review to the quality of the medicinal product. Application of QRM can be done by both proactively and retrospectively. It was adopted by European Union and PIC/S†¡ in Annex 20 of EU and PIC/S GMP guides. In pharmaceutical industry, Quality System is important criteria and QRM is a valuable component of an effective quality system. The QRM should ensure that the evaluation of the quality risk is based on some criteria like knowledge about science, experience with the different process and ultimately links to the protection of patient. It also ensures the effort level, formality and documentation of the QRM process is appropriate with the level of risk. Product quality should be maintained throughout the product lifecycle such that the attributes as it is important to the quality of the drug product which remain consistent with those used in the clinical studies. It can further ensure the quality of drug product to the patient by providing a proactive means to identify and control potential quality issues during development and manufacturing. It can facilitate better and more informed decisions, and can beneficially affect the extent and level of direct regulatory oversight. Guidance to ICH Q9 provides principles and tools for QRM which can be applied to different aspects of pharmaceutical quality includes development, manufacturing, inspection and