Quality Risk Management (QRM) in Pharmaceutical Industry: Tools and Methodology

Das, Amrita and Kadwey, Praveen and Moorkoth, Sudheer (2014) Quality Risk Management (QRM) in Pharmaceutical Industry: Tools and Methodology. International Journal of Pharmaceutical Quality Assurance, 5 (3). pp. 13-21. ISSN 0975 9506

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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 Harmonization (ICH) has developed various guidelines to protect the quality of medicines along with its safety and efficacy. QRM is currently approaching to be a 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 paradigm, 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 change which is risk free. 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. 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.

Item Type: Article
Uncontrolled Keywords: Quality risk management (QRM); ICH Q9; Implementation; Tools; Methods; Process; Technology transfer.
Subjects: Pharmacy > MCOPS Manipal > Pharmaceutical Quality Assurance
Depositing User: KMC Manipal
Date Deposited: 29 Sep 2014 04:20
Last Modified: 29 Sep 2014 04:20
URI: http://eprints.manipal.edu/id/eprint/140753

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