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Chapter 19 ICH Q7: APIs for Use in Clinical Trials
16-17 March 2010
Berlin, Germany
Please click here to view the program of this conference or course
To book for this program, just click on the option:
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At this conference we offer a Conference Exhibition.
Please click here in order to view the registration form (PDF) for exhibitors.
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Objectives
During this education course GMP requirements for a special group of APIs - ‘APIs for use in clinical trials’ - will be discussed in detail. The Education Course is organised in three parts:
- Legal Requirements for APIs in Development
- Process Matters in API Development
- Quality Aspects in Development
Background
Section 19 of the internationally harmonised ICH Q7 provides specific guidance for the manufacture of APIs for investigational use during development. According to ICH Q7 ‘(…) The controls used in the manufacture of APIs for use in clinical trials should be consistent with the stage of development of the drug product incorporating the API (…). Once drug development reaches the stage where the API is produced for use in drug products intended for clinical trials, manufacturers should ensure that APIs are manufactured in suitable facilities using appropriate production and control procedures to ensure the quality of the API (…)’.
In 2006 the ICH Q8 guideline “Pharmaceutical Development” came into operation. This guideline is intended to provide guidance on the section ‘Pharmaceutical Development’ of Module 3 CTD (Common Technical Document). This guideline together with the provisions of Section 19 of ICH Q7 and the Clinical Trials Directive which was implemented in 2004 is relevant for API manufacturers producing APIs for use in clinical trials.
Participants have the opportunity to choose 2 out of 4 parallel sessions, where the following specific topics can be discussed in more detail.
- Collecting and compiling analytical data
- Identifying process parameters needed for process validation
- Collecting data necessary to set up cleaning validation
- Qualification in development
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