Description
The draft of ICH Q10 is the latest document that aims to define
the requirements for a quality system for pharmaceutical
operations. It discusses how the function of the system should
evolve during pre-market operations, what its function is when a
drug is marketed and how opportunities for product improvement
should be identified and implemented throughout the product life
cycle. The main element discussed in Q10 is what management,
especially senior management, should be responsible for in
assuring an effective Quality System. Other important elements
receiving an emphasis in Q10 are the Quality System
components such as change control, deviation control, CAPA,
root cause determination, input/process/output monitoring,
product reviews and documentation.<br><br>
This course analyzes the content of Q10 and compares it with
previous standards including the FDA Guidance on Quality
Systems and ISO 9000. It analyzes its relationship with Q8
(Product Development) and Q9 (Risk Management) and the FDA
Guidance on their Six-Systems Inspection Program and
discusses the quality systems to which Q10 refers with particular
reference as to how such systems can be effectively managed &
integrated in accordance with Q10.<br><br>
Throughout the course interactive discussion on this new, most
important and far reaching Guideline will be encouraged.
