01.07.2010

Chemist

Max Lazar

Max Lazar looks back on an outstanding career within the pharmaceutical industry. For more than 35 years he was working with Hoffmann-La Roche. Following his retirement, he established a consulting business specializing in API GMP issues and the training of personnel covering the ICH Q7 Guidance. His more than 40-year career in the pharmaceutical industry includes numerous memberships in professional organisations and chairs of committees.

Max Lazar graduated from Brooklyn College of the City University of New York where he majored in Chemistry.

From 1994 to 2001 Max Lazar was Vice President, FDA & DEA Compliance at Hoffmann-La Roche. In that position he was responsible for compliance oversight of all of the Roche USA businesses including Active Pharmaceutical Ingredients, Pharmaceuticals, R&D, Diagnostics, Fine Chemicals and Vitamins.

As a voting member of the ICH Expert Work Group (EWG) that developed and negotiated the ICH Q7 Guidance, Max Lazar is uniquely qualified to share and explain the EWG's intent of this new guidance. His involvement in this new API GMP predates the ICH activity itself.

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 author or co-author of the following chapter of GMP Compliance Adviser:

  • 17.C Suppliers