Abstract

OVERREVIEW OF QUALITT RISK MANAGEMENT

Kuncha Manasa*, Dr. B. Venkata Ramana, C. Parameshwari and Dr. K. V. Subba Reddy

Abstract

Quality risk management (QRM) is one of the most important tasks when it comes to pharmaceutical industry.it is because the industry produces medicines whose quality is directly related to the patient health. International conference on harmonisation (ICH) has developed various guidelines to protect the quality of medicines along with its safety and efficacy QRS is currently approaching to be mandatory practice in industries. ICH Q9 guideline can help industry start with its risk management plan but its implementation and practice seems to be challenging. There should be a risk management plan in place together with QBD (quality by design) and PQS (pharmaceutical quality systems) to build quality in the final product. Being a non-mandatory requirement till now. Industries hesitate to implement the new Para diagram, Q8 Q9 and Q10, which will become a burden for industries to meet the regulatory challenges. But it is important to understand that it is high time to bring a challenge which is risk free. This article discusses the process of risk management to achieve quality of medicinal product and tools which can be used for risk assessment during manufacturing practices under taken but small or medium sized WHO approved plants. 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 intern benefits the industry and patient.

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