ICH Q7 Guidelines and Practical Approaches to Manufacturing APIs

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ICH Q7 Guidelines and Practical Approaches to Manufacturing APIs

ICH Q7 Guidelines and Practical Approaches to Manufacturing APIs

Instructor : Max Lazar

Product Id : 600204

Overview: Active Pharmaceutical Ingredient Good Manufacturing Practices (API GMP) are established and defined by the ICH Q7 Guidance.

The international supply chain associated with API manufacturing was one of the greatest drivers for the development and international adoption of these expectations by regulators world-wide. The growth in the number of FDA inspections of API producers outside of the USA also played a major role in motivating international interest in the development of a "universal" API GMP.

ICH Q7A Guidelines ( later renamed by ICH as Q7 ) and practical approaches will be examined during this program. All the sections contained within the issued and internationally adopted Guidance will be surveyed and discussed, as only it can be by this actual author of the approved guidance. There are many consultants and "experts" that teach this subject, but almost none have first-hand knowledge of its development.

Some of the behind the scenes background will be discussed so that participants will be able to better understand the true intent of the expert work group's negotiations. What are some key differences from Drug Product GMP and why were these differences established in Q7?

How should producers apply the guidance and how should users or purchasers of API utilize Q7 to their own benefit will be part of the subject matter. It is important to note that there are differences between drug product and API GMP and they need to be interpreted and applied correctly.

The nineteen Sections of Q7 and even the definitions used within the document have been carefully developed and written. This Webinar will help participants focus on the key parts and recognize where professional attention will benefit firms and organizations and where and when further training should be seriously considered.

Applying API GMP in the real world environment as intended by Q7 is as important as the guidance itself. Q7 has built-in flexibility in the application and intent of the API GMP which generally does not exist in drug product GMP regulations. The somewhat unique aspects associated with API is discussed and helps participants better under and apply these GMP.

Why should you attend: Are you new to the subject of API GMP, confused by the ICH Q7 Guidelines or how they should be applied by producers and suppliers of API as intended by the authors of Q7, then this Webinar is for you. This course, taught by one of the voting members of the Expert Work Group that negotiated this international guidance, will provide greater insight into the API GMP. Insight that only can come from a direct participant in the guidance's development and negotiation. The program will identify which of the guidances sections that he considers most important, and how should they be implemented on a real-world basis. This is a rare opportunity to hear from and interact directly with a member of the ICH Expert Work Group that wrote Q7 and gain from his more than 40 years of experience in the drug and food additive related industries.

Areas Covered in the Session:

Impact of FD&C Act
History of API GMP
Use of 21 CFR Parts 210 and 211
Nineteen Sections Surveyed
Importance of Definitions in Q7
Where is there Flexibility in API GMP Application
What are key Sections
Why the need for Q7?
Are Q7 and 211 differences justified?
What do producers need to do?
What do purchasers of API need to do?

Who Will Benefit:

Quality Unit Supervisors/Managers/Directors
Manufacturing Supervisors/Managers/Directors
Support Functions to Quality or Manufacturing
Regulatory Affairs personnel responsible for GMP Compliance and filings
Support personnel responsible for GMP Related activities such as Calibration and Testing Functions
Validation personnel
R&D Professional, Supervision and Management

Max Lazar retired from Hoffmann-La Roche Inc. in 2001 after 35 years, where he was Vice President, FDA & DEA Compliance. In that position he was responsible for compliance oversight of all of the Roche USA businesses including Active Pharmaceutical Ingredients, Pharmaceuticals (Solid, Liquid, and Sterile), R&D, Diagnostics, Fine Chemicals and Vitamins. Following his retirement, he established a consulting business specializing in API GMP issues and the training of personnel covering the ICH Q7A Guidance as well as the Excipient GMP (IPEC) Guidance. As a voting member of the ICH Expert Work Group (EWG) that developed and negotiated this new international standard, Max is uniquely qualified to share and explain the EWG’s intent of this new guidance. His involvement in this new API GMP pre-dates the ICH activity itself.

His more than 40-year career in the Pharmaceutical Industry includes numerous memberships and chairs of committees. He founded and chaired the Pharmaceutical Manufacturers Association’s Bulk Pharmaceutical Committee of the Quality Control Section. This chair lasted thru the reorganization of PMA into PhRMA and until Max’s retirement in 2001. He has presented at numerous meetings and training programs including SOCMA, PDA, DIA, PhRMA, Barnett, and IIR both domestically and overseas.
,br> Max was named Topic Leader for the Pharmaceutical Research and Manufacturers Association’s (PhRMA) ICH Q7A team that developed the API GMP document for ICH. He represented USA industry at the PIC/S Canberra Conference which preceded the ICH API activities and worked with FDA during the 1980 – 2000 era addressing all of the API industry related regulatory issues including the 1987 NDA Re-Write Guidelines and GMP activities. 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.

He was Vice Chair of the USP Pharmaceutical Waters Expert Committee (2000-2005) and had been re-elected to another 5-year term (2005-2010) as a member on this USP Expert committee. In 2011, USP has appointed Max to three USP Expert Panels covering various Water Subjects of interest to USP. Max conducts training and consultations on API GMP (ICH Q7A) and other FDA Compliance issues. While specializing in API, Max’s experience provides him with expertise in many areas of FDA compliance including Excipients, laboratory, documentation, sterile and oral dosage forms as well as devices, diagnostics and radiopharmaceuticals.

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 is 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. He has contributed to several books dealing with APIs, and has written and published several guidances covering Bulk Pharmaceutical Chemicals (API) as chair of the PhRMA and PMA Bulk QC Committee and Workgroups. He resides in Surprise, AZ.

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