ICH Q7 FDA Guidance – Its Structure, History, Application and Writer's Intent

Why Should You Attend:

This program, together with Auditing API Facilities, create an opportunity to better prepare and successfully complete an FDA inspection of an Active Pharmaceutical Ingredient (API) facility.

Professionals responsible for GMP compliance of API must truly understand what is discussed in this program and be able to properly apply all critical sections and requirements to the important areas of an API facility and all its written procedures and documents.

Professionals responsible for facilities and operations responsible for making, maintaining, storing, distributing, testing or developing API require a thorough understanding of Q7 and its applicability to a firm’s regulatory responsibility. The cost of this program is small compared to the risks associated with not knowing and understanding the required regulatory concepts for API operations.

Knowing what is actually required to produce an acceptable API, properly design and construct an acceptable API facility, correctly control the process with properly documented records and test results are all critical for the success of every API Facility. If you do something . . . it better be RIGHT!

Simply reading this Guidance is not good enough for proper application of the GMP. What IS required is an understanding of the intent of the writers of this document. This webinar provides attendees of this program the unique opportunity to hear directly from a voting member of the Expert Work Group that negotiated and wrote the API GMP. People that participate in this Webinar will leave the program with information and insider information available only from the program’s presenter. This information is key to properly applying or not applying all the sections of Q7.

Areas Covered in the Webinar:

• Why was there a need to write API GMP even though Drug Product GMP (21 CFR Part 210 and 211) already existed?
• What caused ICH to take action?
• How was this need address initially and finally?
• Who participated and why?
• Identify Sections of Q7
• Discuss KEY Sections
• Examine important parts of Key Sections
• Discuss how to apply Q7
• Opportunity to ask specific questions about Q7 that is not obvious in this oversite webinar.

Free Materials:

• Program Slides
• Electronic copy of FDA Q7 Guidance

Who Will Benefit:

Personnel responsible for

• Producing, testing, storing or distributing API
• Drug intermediates, excipients, developing, or registration of these with FDA.
• Managers, site managers, Production, Quality, Development, Maintenance, Storage/Distribution Management of API Firms.
• Repacker or Relabelers of API

Max Lazar
Owner, FDA Regulatory Compliance Consulting

Max Lazar retired from Hoffmann-La Roche Inc. in 2001 after 35 years. At that time, he was 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, he 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 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. Max 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 an internationally harmonized good manufacturing practice guidance for active pharmaceutical ingredients used in human drug products.”

He is a member of numerous professional organizations. He has been on the Editorial Board of the Journal of GXP Compliance, the Editorial Advisory Board of Pharmaceutical Outsourcing and the Advisory Board of the GMP Manual, Maas & Peither AG – GMP Publishing. Max is listed in numerous editions of Who’s Who including Who’s Who in America and is a graduate of Brooklyn College of the City University of New York.

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