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. Venkatesh Prasath.N, Vijayaraghavan.K, Syed Areef.H, Preethi.B and P.Sriram charan


International Conference on Harmonization, or ICH, refers to efforts to standardise the processes involved in registering new drugs for use in humans. Data on ICH, its activities, or guidelines is made public so that the three ICH regions (the United States, Japan, and also the European Union) can collaborate to discuss and adopt common norms. In recent years, the regulations governing the release of generic pharmaceuticals have taken on greater significance. The pharmaceutical industry is increasingly international in scope, from research to production. In this day and age, harmonisation is more important than ever because it facilitates the distribution of labour, the efficient use of resources, and the availability of life-saving medications. As well as ensuring quality, safety, and efficacy safeguards, the purpose of harmonisation seems to be to improve the use resources (human, animal, or otherwise) and avoiding needless delays in the global rollout of new drugs. The current review is centred upon Quality Risk Management in relation to the ICH quality control recommendations (Q9). In order to guarantee quality assurance for a finished item or service, quality control is employed. It could include everything an organisation deems necessary for the effective administration and assurance that their procedures are correct. attributes of a good or service Typically, this means conducting extensive inspections and tests to ensure that products and services are of the highest quality. The fundamental goal of this procedure is to ensure that the offered goods and services are reliable, user-friendly, secure, and sustainable. Risks to the quality of a drug product are constantly present throughout the product's lifecycle, and quality risk management is a methodical approach to identifying, mitigating, communicating, and reviewing these risks. There needs to be a solid foundation in science and a direct correlation to the patient's safety in order for the risk assessment to be reliable; and Quality risk management should be conducted with the amount of effort, formality, the documentation that is appropriate for the degree of risk.

Keyword : Quality Risk  Management(Q9), ICH , Quality Control, Drug Development.

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