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Pharmaceutical Regulatory Affairs: Open Access

ISSN: 2167-7689

Open Access

Prominence of pharmaceutical quality system in the product life cycle


2nd International Conference and Exhibition on Pharmaceutical Regulatory Affairs

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

Sunny kumar Mamidala, Harsha Pulipati and M. Vamshi Krishna

Posters: Pharmaceut Reg Affairs

Abstract :

Pharmaceutical Quality System is a new ICH tripartite guideline having reached its step4 of the ICH process and its under the quality guidelines considered as ICHQ10. It describes one comprehensive model for an effective Pharmaceutical Quality System that is based on International standard Organization (ISO) quality concepts, includes applicable GMP regulations & complements ICHQ8 pharmaceutical Development & ICH Q9 Quality risk management. It can be implemented throughout the different stages of a product lifecycle and is applicable to manufacturing sites. The aim of ICH Q10 is to enhance the quality and availability of medicines around the world in the interest of public health. The guideline applies to the system supporting the development and manufacturing of pharmaceutical drug substance and drug product, including biotechnological & biological products. Throughout Product Lifecycle i.e., Pharmaceutical Development, Technology Transfer, Commercial Manufacturing & Product Discontinuation. The topic of discussion includes the scope of the guideline and application. The elements of ICH Q10 should be applied in a manner that is appropriate and proportionate to each of the product lifecycle stages , recognizing the differences among the different goals of each stage.

Biography :

Mr. Sunny Kumar has completed his B.Pharm in K.U.and presently pursuing their M.S. in Pharmaceutical Analysis and Quality Control from JNTUHYD. He is a member of IPGA.

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