Leveraging Existing Management Systems to Comply with Both cGMP and Process Safety Requirements

Many companies who are regulated by current Good Manufacturing Practices (or cGMP) are discovering that they are also required to comply with process safety management regulations such as PSM in the U.S. or Seveso or COMAH in Europe. And chemical and petrochemical companies who have been regulated for years under PSM are now starting to produce pharmaceutical products that are regulated under cGMP.

While cGMP and PSM regulate different hazards, the management systems that are needed to comply with each regulation are often the same. This paper will address the elements of the U.S. PSM regulation and compare those requirements to the US cGMP regulations to show how the same management systems can be used to simultaneously comply with both regulations.

Introduction

Process safety regulations protect people, assets, and the environment by managing hazards associated with the release of hazardous chemicals and other energy sources.

Current Good Manufacturing Practices (or cGMP) regulations protect people and animals from the adulteration of food and drugs that makes the product impure, unsafe, or unwholesome. 21 US Code 342 & 351 define adulterated food and drugs in detail.

While the goals of the two regulations are different, they both contain similar requirements that can utilize the same management systems to comply with both regulations simultaneously. This paper will compare the key elements from the U.S. Process Safety Management (PSM) requirements from 29 CFR 1910.119 with the International Conference on Harmonization (ICH) Q7 which is cGMP for Active Pharmaceutical Ingredients (APIs).

The cGMP requirements for food, dietary supplements, drugs, and excipients have similar requirements, but the related references will not be detailed in this paper. For more information on these topics, please reference 21 CFR 110 for cGMP for human food; 21 CFR 111 for cGMP for dietary supplements; 29 CFR 210 for drugs; 21 CFR 211 for finished pharmaceuticals; and the International Pharmaceutical Excipient Council (IPEC) for cGMP excipient guidelines.