One Man s Opinion
API
Max S. Lazar President FDA Regulatory Compliance Consulting
Background
After 45 years in the drug and API industry, I have seen and experienced many things both as a member of the FDA s regulated industries and as an active participant and I trust, contributor to the development of policies and practices used to positively impact our society and the Good Manufacturing Practices and other standards that are used for Active Pharmaceutical Ingredients (API), excipients, drug products, and other regulated materials.
I feel it is time that I share my personal views on what is happening or not happening in a number of industrial and regulatory areas. History tends to be a good educator if one takes the time and interest to learn from it. Both regulators and drug firms have a responsibility to assure that high quality materials and products are used and manufactured for the public s consumption. However, as we all know, there have been too many instances of both industrial and regulatory failures which have caused illnesses and even death. All of which were most likely preventable or could have been minimized if proper actions were taken or illegal acts were discovered early enough.
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