2005D-0288 International Conference on Harmonisation; Draft Guidance on Q9 Quality Risk Management
FDA Comment Number : EC4
Submitter : Mr. Gordon Johnston Date & Time: 10/12/2005 04:10:10
Organization : Generic Pharmaceutical Association
Category : Drug Association
Issue Areas/Comments
Dear Sir or Madam:

The Generic Pharmaceutical Association (GPhA) appreciates the opportunity to comment on the above referenced Draft Consensus Guideline. GPhA represents 98% of generic drug manufacturers whose drugs are dispensed for over half of all prescriptions filled in the United States, but representing less than 10% of all drug expenditures. GPhA is the united voice of the generic drug industry and is committed to pharmaceutical quality. GPHA would like to thank the Agency for this opportunity to provide input on the International Conference on Harmonization Draft Guidance on Q9 Quality Risk Management.

GPhA supports the concepts of the Draft Guidance on Q9 Quality Risk Management (Draft Guidance). However, we wish to provide comments for FDA consideration as the Draft Guidance moves forward. The introduction to the Draft Guidance on Q9 Quality Risk Management stated that the purpose of the document is to serve as a foundation or resource document that is independent yet supports other ICH Quality documents and complements existing quality practices, requirements, standards, and guidelines within the pharmaceutical industry and regulatory environment. The Draft Guidance represents a compendium of risk management principles and tools. As such, the Draft Guidance is unlike other ICH guidances in that it provides no specific pathways or recommendations for industry or regulators.

GPhA recognizes that quality and risk management are important, but broad topics. ICH Q9 as proposed provides an abstract of many risk assessment, control and management concepts. These high level principles may provide a menu of possible tools that can be used to mitigate risk in a planned and organized manner. However, the Draft Guidance does not include recommendations on practical application of these principles in an industrial or regulatory setting, such as, how and when these concepts should be employed. In order to maximize the use of ideas embodied in ICH Q9, GPhA recommends that industry and FDA engage in training and further discussions to better understand how ICH Q9 should be used in practice. Examples of how risk management can be applied to industry operations from a regulator?s perspective would certain aid in the advancement of industry?s understanding of this issue.

GPhA looks forward to working with FDA to develop a better understanding of how industry can use ICH Q9 to maximize the benefits of the risk management tools addressed in the Draft Guidance.