Journal of Developing Drugs
Open Access
ISSN: 2329-6631
+44 1478 350008
ISSN: 2329-6631
+44 1478 350008
Jasbir Rattu
CeutiQus Ltd., UK
Posters & Accepted Abstracts: J Develop Drugs
Quality risk management (QRM) is an enabling process that supports the product life cycle and is an integral part of an organisation�s pharmaceutical quality system (PQS). The ultimate goal of the QRM process is to bring focus and effort to the issues that impart the highest risk to product quality and/or patient safety. Therefore, as QRM is ultimately linked to the protection of the patient, a modern PQS cannot truly function properly in the absence of an effective, integrated QRM system. QRM is a systematic process for the assessment, control, communication and review of risks to the quality of the medicinal product. It can be applied both proactively and retrospectively. Therefore, the objective is not just to identify risk, but to provide information to help make better and informed decisions to mitigate and reduce risk, thus improving the process. Hence, it is critical to understand and effectively and optimally use the most appropriate risk management tools and approaches. The consistent and effective analysis of risks associated with manufacturing processes and quality systems typically leads to more robust decisions reduces uncertainty and leads to greater confidence in outcomes. These QRM elements must be embedded throughout the organisation through policies and procedures and reinforced via effective training. This presentation discusses best practice and my experience of successfully implementing this in high risk areas such as regenerative medicine but also other areas of the biopharmaceutical industry.
Email: j_rattu@hotmail.com