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.
Other Courses of Interest
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Drug Product Stability and Shelf-Life
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ICH-Q7
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INDs/NDAs/CTDs
Orphan Drug Application and Submission
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