Developing Specifications for Drug Substances (APIs) and Drug Products
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Who Should Attend
This course is intended for personnel from both Generic and
Research-based pharmaceutical industries including:-
Pharmacists
- Analytical and Synthetic Chemists from R&D
- Staff from Production Departments and from QA and QC
- Regulatory Affairs Personnel
- Pre-Clinical Scientists will benefit from the course by gaining a
better understanding of the complexities of the drug
development process and of the importance of setting
specifications
Description
The course will present a review of the activities that will occur
in the process of setting specifications for Drug Products and
APIs made by synthesis or by conventional fermentation.
Critical specification issues for drug substances and drug
products will be reviewed, specifically focusing on the
interactions and dialogue necessary between analytical and
pharmaceutical/chemical groups during the development of
specifications. Using practical examples, the importance of
understanding “real-life” constraints and regulatory
requirements will be highlighted across a wide variety of drug
product formulations. Strategies for Out-Of-Specification (OOS)
findings will be discussed. The course will review the latest
activities of ICH with respect to specifications for drug
substances and drug products. You will benefit in your job by
applying facts learned in this course. Increases in productivity
will result. An open and interactive environment is encouraged
throughout the course.
Please note Optional Fourth Day on ICH Q7A; GMP Guide for Active Pharmaceutical
Ingredients