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Short Course

Course Information
Course Title: Control of Impurities in Pharmaceutical Products: Impurities, Degradants, Residual Solvents and Elemental Impurities
Categories: 1 - Liquid Chromatography
2 - Pharmaceutical Sciences
3 - Gas Chromatography
Instructor(s): Gregory Martin Course Number: 163
Affiliation: Complectors Consulting
Course Date: 03/19/2013 - Tuesday Course Length: 1 Day Course
Start Time: 08:30 AM End Time: 05:00 PM
Fee: $480 ($680 after 2/18/13) Textbook Fee:

Course Description
This course is designed to provide an overview of impurities which must be controlled in pharmaceutical products, detailed review of the guidance documents from ICH and USP related to each of the categories of impurities and strategies to address each, including reporting of test results. Topics for discussion include drug-related impurities, including process impurities, normal degradation products and potential genotoxic impurities and general impurities (not structurally related to the drug substance), such as residual solvents and elemental impurities.

Target Audience
Laboratory chemists, supervisors or managers responsible for development, testing, release or stability of pharmaceutical drug substances or drug products, and Quality Assurance or Regulatory Affairs personnel responsible for review or reporting of data for drug substances or drug products.

Course Outline
1. Overview of Impurities in Pharmaceutical Products Requiring Control
a. Drug Substance Impurities (ICH Q3A)
b. Drug Product Impurities and Degradation Products (ICH Q3B)
c. Potential Genotoxic Impurities (FDA and EMEA Guidances)
d. Residual Solvents (ICH Q3C; USP <467>)
e. Elemental Impurities (ICH Q3D; USP <231, 232, 233>)
2. Drug Related Impurities
a. Process Impurities
i. Chromatographic tests
ii. System suitability tests
b. Degradation Products
i. Forced Degradation Studies
ii. Chromatographic tests
iii. System suitability tests
c. Potential Genotoxic Impurities
i. Understanding the requirements
ii. Predicting degradation products
iii. Structural alerts
d. Establishing specifications
3. General Impurities
a. Residual Solvents
i. Understanding the requirements
1. Solvents covered
2. Classes of solvents
ii. PPM and PDE
iii. Testing methodology
iv. Strategies to reduce testing
b. Elemental Impurities
i. Understanding the requirements
1. Heavy Metals: The current standard
2. Elemental Impurities : The coming standard
3. Questions ande Discussion

Course Instructor's Biography
Greg Martin is President of Complectors Consulting (www.complectors.com) which provides consulting and training in the area of Pharmaceutical Analytical Chemistry. He has particular interest in QbD/Lean approaches to dissolution testing, impurity methods, method lifecycle (development/validation/transfer) and instrument qualification, and is passionate about using good science and sound logic to achieve high quality results, consistent with cGMPs, while minimizing resources. Mr. Martin has over 25 years experience in the pharmaceutical industry and was Director of Pharmaceutical Analytical Chemistry (R&D) for a major PhRMA company for a number of years. In addition, he has volunteered for the USP for over 10 years, and currently serves as Vice Chair of the General Chapters – Physical Analysis Expert Committee, and serves on Expert Panels on Validation and Verification, Weights and Balances and Use of Enzymes for Dissolution Testing of Gelatin Capsules. He is also Chair-elect of the AAPS In Vitro Release and Dissolution Testing Focus Group. He can be contacted at greg.martin@complectors.com.