FDA GMP Requirements for API (Active Pharmaceutical Ingredients) - Just what do YOU need to do?

While this topic may appear easily addressed, appearances can be deceiving. This program will examine some history, real-life experiences and discuss the real facts about GMP for Active Pharmaceutical Ingredients. Just what is important to firms, producers of API and consumers of the API. Discussed will be what regulations apply and what guidance is important. Also examined are various ICH and FDA guidance that enters the everyday business of API manufacturing and use. Understanding what is examined during FDA inspections is important so that the firms can manage and complete such inspections successfully. This Webinar will also examine where there exists flexibility in the application of GMP.

• FDA regulations and guidance
• FD&C Act
• Producing API
• Where and how does GMP apply?
• Historical examination of Federal FDA Legislations
• The USA and other country/world rules
• ICH Guides
• How GMP and other FDA Guidance's relate?
• Systems examined by FDA
• API versus Drug Products
• FDA's Expectations
• The key element of producing API
• Purchasing API
• CMO of API

This program will prepare you by improving your understanding of what the FDA examines during FDA's inspections and on-site visits. With this information, you will be better prepared to get through a successful FDA encounter. This is easy to read about, but much more difficult to apply and prepare correctly for the real-world experience you will encounter during an FDA review.

• Quality control
• Quality assurance
• Regulatory affairs
• Manufacturing
• Development
• Warehousing/Distribution
• Sales/Marketing

Max Lazar retired from Hoffmann-La Roche Inc. in 2001 after 35 years.  At that time, he was the Vice President, FDA & DEA Compliance reporting to the firm’s President. Over his career, he progressed from a QC bench chemist through increasing titles and responsibilities, reaching his ultimate responsibility for Compliance oversight of the Roche USA businesses including Active Pharmaceutical Ingredients, Pharmaceuticals, R&D, Diagnostics, and Fine Chemicals and Vitamins.  Following his retirement, Max was approached to establish a consulting business specializing in API GMP issues and the training of personnel in both API and other drug-related GMP.  His more than 50-year career in the Pharmaceutical Industry includes numerous memberships and chairs of committees.

He represented the USA industry at the PIC/S Canberra Australia Conference which preceded the ICH API activities and worked with FDA during the 1980 – 2000 era addressing API industry-related regulatory issues. He was one of five invited industry representatives at the WHO/CDC/FDA Diethylene Glycol Contamination Prevention Workshop that followed the Haitian tragedy where almost 100 children died. This workshop developed recommendations for consideration by the Pan American Health Organization and WHO. He was named as PhRMA’s representative on the FDA PQRI initiative that developed the initial Bulk Substance projects and is a current member of existing USP water panels.    

For his contribution to Q7A, he was awarded the USA FDA Commissioner’s Special Citation “For outstanding cooperation and achievement in developing internationally harmonized good manufacturing practice guidance for active pharmaceutical ingredients used in human drug products.” He was honored and recognized in 2019, by The Marquis Who’s Who Publications Board, as a recipient of the “Albert Nelson Marquis Lifetime Achievement Award”, an honor reserved for” Marquis Biographees who have achieved career longevity and demonstrated unwavering excellence in their chosen fields.” He is a member of numerous professional organizations and is listed in numerous editions of Who’s Who including Who’s Who in America.