The Relationships Between ICH Q10 Pharmaceutical and FDA Quality Systems Supporting ICH Guidances Approach for GMP

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Deadline: April 10, 2013 | Date: April 11, 2013

Venue/Country: san francisco, U.S.A

Updated: 2013-03-28 00:02:40 (GMT+9)

Call For Papers - CFP

The FDA published the Quality Systems Approach to Pharmaceutical Good Manufacturing Practices (QSAPGMP) in September of 2006. The International Conference on Harmonization (ICH) finalized ICH Q10, Pharmaceutical Quality Systems, in June of 2008.

Both of these guidances emphasize the important role Senior Management has in carrying out its responsibilities to not only lead but also to participate in the design and maintenance of a pharmaceutical quality system. Senior Management is responsible for directing the use of resources to ensure that quality operates throughout the product lifecycle so that products meet their performance expectations and fulfill their customer and user needs and requirements as it relates to the product. It should also be mentioned that ICH Q10 is, as I call it "ISO-Like" The United States, EU, and Japan have now adopted ICH Q10.

ICH Q10 is not a stand-alone document but part of a quality system, and like a quality system, its subsystems must work together to be effective. These other subsystems are the ICH guidance, (1)Q7, Good Manufacturing Practices, (2) Q8,Pharmaceutical Development (3)Q9, Quality Risk Management,(4) Q10, Pharmaceutical Quality System, (5) Q11, Development and Manufacture of Drug Substances. Of course, the FDA guidance, Quality Systems Approach mentioned above is very similar in concept but is organized differently. If you understand the quality concepts of Juran and Deming, and other "quality gurus", then you are well on your way mastering these guidances.

This webinar will introduce the quality principles inherent in the guidances mentioned above. The starting point is a discussion of quality concepts, definitions, and principles. While ICH Q 10 is the primary subject of discussion, it is important to see the relationships between ICH Q 10 and the other guidances. The discussion will contrast the content of compliance documents such as Part 210-211 & Part 820 and their preambles to ICH guidances. This will establish the foundation for describing the roles of Senior Management in the design, implementation, and maintenance of the quality system. The primary discussion points include management and quality responsibilities, the use of resources, design, and risk, the product lifecycle, the quality manual, monitoring, and Corrective and Preventative Actions (CAPA).