Opportunities and challenges in the implementation of ICH Q9 with emphasis to a WHO approved pharmaceutical plant

Venkatesh, Nagendra, Pramod Kumar
Int J Res Pharm Sci   unpublished
Quality Risk Management (QRM) is one of the most important tasks when it comes to pharmaceutical industry, as the quality of products produced by it is directly related to patient health. International Council on Harmonization (ICH) has developed various guidelines to protect the quality of medicines manufactured by a pharmaceutical plant; one such is the ICH Q9 guideline. Implementing QRM is currently approaching to be a mandatory practice. But the question arises whether the guideline
more » ... tation goes hand in hand with its implementation in the industries? There are still many things which need improvisation in aspects of interpretation and implementation of the harmonized guideline. ICH Q9 provides a standard path for the industries to practice risk management activities which allows a formal acceptance by GMP regulators. Industries and regulators can make use of various risk management plan such as European risk management strategy, risk management guidance, risk-ranking and filtering tool of 2004 of FDA. This article discusses the process of risk management to achieve quality of medicinal products and tools which can be used for risk assessment during manufacturing practices undertaken by small or medium sized WHO approved plants. Effective QRM implementation can facilitate better and well-versed decisions which can provide regulators with greater assurance of a company's ability to deal with possible risks. Considering the higher incidences of product recalls, the implementation of Q9 together with Q8 will help the Indian pharmaceutical companies to launch safer products in the market, which in turn benefits the industry and the patient.