ROLE OF ICH GUIDELINES IN PHARMACEUTICAL QUALITY RISK MANGAMENT-REVIEW

K. Akilesh*, Dr. D. Sudarshan Reddy, S.V. Siababa and Dr. B. Rajkamal

ABSTRACT

ICH is “International Conference on Harmonization” of technical requirements for registration of pharmaceuticals for human use. The goal of ICH is to discuss and establish common guidelines by bringing together three ICH regions i.e. USA, Japan and EU and to make information available on ICH, its activities and guidelines. The guidelines have become more relevant for Generic’s Drug Approval. Drug Development and manufactures are more and more global. The present discussion of the review is on ICH guidelines for quality control focussing mainly on Quality Risk Management (Q9). Quality control is a process that is used to ensure a certain level of quality in a product or service. It might include whatever action a business deems necessary to provide for the control and verification of certain characteristics of a product or service. Most often, it involves thoroughly examining and testing the quality of products or the results of services. The basic goal of this process is to ensure that the products or services that are provided meet specific requirements and characteristics, such as being dependable, satisfactory, safe and fiscally sound. Quality risk management is a systematic process for the assessment, control, communication and review of risks to the quality of the drug product across the product lifecycle. Two primary principles of quality risk management are: • The evaluation of the risk to quality should be based on scientific knowledge and Ultimately linked to the protection of the patient; and • The level of effort, formality, and documentation of the quality risk management process should be commensurate with the level of risk.

Keywords: Quality Risk Management (Q9), ICH, Quality risk management.