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Pharmaceutical Regulatory Affairs: Open Access

ISSN: 2167-7689

Open Access

ICH Q10: Pharmaceutical quality system


2nd International Conference and Exhibition on Pharmaceutical Regulatory Affairs

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

Sandeep Kanna and N. Vishal Gupta

Posters: Pharmaceut Reg Affairs

Abstract :

ICH Q10 describes one comprehensive model for an effective pharmaceutical quality system that is based on International Organization for Standardization (ISO) quality concepts, includes applicable good manufacturing practice (GMP) regulations and complements ICH Q8 ?Pharmaceutical Development? and ICH Q9 ?Quality Risk Management?. It aims to promote a paradigm shift from discrete GMP compliance procedures at each stage of the product life cycle to a comprehensive quality systems approach over the life cycle of the product. It demonstrates industry and regulatory commitment to robust quality systems and technical innovation and enhance assurance of consistent availability of medicines around the world. It?s guidance applies to the systems supporting the development and manufacture of pharmaceutical drug substances and drug products, including biotechnology and biological products. The elements of ICH Q10 should be applied in a manner that is appropriate and proportionate to each of the product life cycle stages, recognizing the differences among and the different goals of each stage. The key objectives are to ? Achieve product realization ? Establish and maintain a state of quality control ? Facilitate continual improvement.

Biography :

Sandeep Kanna is a student of JSS College of Pharmacy, JSS University, Mysore, Karnataka, India. He has completed his B.Pharm from Narasaraopet Institute of Pharmaceutical Sciences, Narasaraopet, Andhra Pradesh, India during the year 2011. Presently he is pursuing M.Pharm in Pharmaceutics. His present interests are in Novel Drug Delivery Systems and Nanoparticulation.

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