New draft Annex 1 provides general guidance that should be used for all sterile medicinal products and sterile active with respect to using the principles of Quality Risk Management (QRM), to ensure that microbial, particulate and pyrogen contamination associated with microbes is prevented in the final product.
It further specifies that Processes, equipment, facilities and manufacturing activities should be managed in accordance with QRM principles that provide a proactive means of identifying, scientifically evaluating and controlling potential risks to quality. Risk assessments should be used to justify alternative approaches to those specified in this Annex only if these alternative approaches meet or surpass the intent of the Annex.
European health authorities’ inspectors will seek scientifically sound, unbiased risk assessments, and the use of QRM principles in the planning, design, control, monitoring, operation, and investigation of sterile product manufacturing processes. The industry must be prepared to develop and employ those QRM principles and risk management methods. This presentation will deal with some of the critical issues of QRM.
Rishikesh is the Plant Manager of Baxter Pharmaceuticals India, Ahmedabad since January 2019 and responsible for delivering manufactured products and inter-plant services that meet safety, quality, cost and on-time delivery goals in support of associated business objectives.
Rishikesh previously worked for GlaxoSmithKline (GSK) and has 21 years’ experience in pharmaceutical and vaccines manufacturing in FDA regulated facilities. His most recent position was Site Director at the Ankleshwar (India) Vaccine Plant.
Rishikesh has global experience with GSK which includes 4 years at the Marietta (PA), USA vaccine manufacturing site
His experience includes working in Operations, Quality, Project Management, and Operational Excellence & Technical Trainings. Rishikesh holds a postgraduate in Pharmaceutical Chemistry from, Indore, India.