FDA Advisory Committee discusses new Quality Guidances and Initiatives

GMP News No. 860

GMP News
19 December 2006

FDA Advisory Committee discusses new Quality Guidances and Initiatives

The agenda for a meeting of the FDA Advisory Committee for Pharmaceutical Science in early October basically contained two topics: an update on International Conference on Harmonisation (ICH) quality issues and the discussion about their impact on current regulatory direction and the discussion about the status, the challenges and next steps for implementing Quality-by-Design.

With regard to ICH's quality topics the committee felt that "ICH guidance is adequate in providing appropriate level of details for both experienced and inexperienced companies for most topics." It recommended the agency though to consult with the industry and to observe submissions for deciding on further guidances. Relative to developing additional guidelines for the new concept "Design Space" the committee preferred a certain flexibility to avoid limiting companies when making their submissions. In the committee's opinion it is also premature to decide on additional guidance for something that has only been existing for a short period of time and in a small number.

Concerning the implementation of Quality-by-Design (QbD) the committee agreed that QbD principles should increase product quality assurance, provide applicants with more flexibility for continuous improvement and decrease the need for FDA regulatory control on post-approval changes.

For the committee it was too early in the process to determine whether plans and efforts for the implementation of QbD were adequate or not. Committee members suggested to keep track of the implemented programmes. With regard to the FDA's query about the development of a specific QbD pilot programme supporting biotechnology the group recommended to consider it.

The summary minutes for the meeting are available at the following address:

ICH's quality initiatives are also part of the following ECA courses and conferences:

You can also book these courses separately:

Prepared by:
Wolfgang Heimes
On behalf of ECA

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