International Journal of

Pharmaceutical Quality Assurance

ISSN: 0975 9506
Peer Review Journal

doi prefix: 10.25258/ijpqa

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1. Quality Risk Management (QRM) in Pharmaceutical Industry: Tools and Methodology
Amrita Das, Praveen Kadwey, Jai Kumar Mishra, Sudheer Moorkoth
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.

Impact Factor: 1.041

UGC approved Journal

This journal is present in UGC approved List of Journals for the purpose of Career Advancement Scheme (CAS) and Direct Recruitment of Teachers and other academic staff as required under the UGC (Minimum Qualifications for Appointment of Teachers and other Academic Staff in Universities and Colleges)

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