Process Analytical Technology (PAT): An ideal or an achievable option for quality assurance?

2^nd International Conference and Exhibition on Pharmaceutical Regulatory Affairs

November 23-24, 2012 Hyderabad International Convention Centre, India

Yacine Sellam

Accepted Abstracts: Pharmaceut Reg Affairs

Abstract :

Process Analytical Technology (PAT) began with an initiative of the Food and Drug Administration (FDA) in USA, during its Science Board Meetings of 11/01 and 4/02. Science Board supported for FDA?s proposal to facilitate innovation in the field of pharmaceutical manufacturing. This decision was materialized by a guideline ?PAT ? A Framework for Innovative Pharmaceutical Manufacturing and Quality Assurance? released in September 2004. The aim of this guideline is to encourage industrials to innovate ?voluntarily? in manufacturing and to give them a guarantee of regulatory approval. PAT refers commonly to a system for designing, analyzing, and controlling manufacturing by timely measurements of critical quality and performance attributes of raw and in-process materials. It suggests the possibility of real time release of final products batches. In this work, we focus on the PAT tools for design, data acquisition and analysis, and on the feasibility of implementing these tools in a pharmaceutical plant to improve the level of quality assurance.

Biography :

Yacine Sellam has obtained his Pharm.D. at the age of 23 years from Algiers? University and he is now a postgraduate student in Analytical Chemistry Applied to Pharmaceutical Products at the same university. He is also a permanent Oncology Pharmacist at the Pierre and Marie Curie Center of Algiers. He has communicated in many regional symposiums and conferences on pharmaceutical quality assurance and regulatory affairs.