Pharma/BioPharma cGMP, including both small and large molecule Pharma processes can leverage their cGMP program for implementation of PSM, as there is a very close correlation between the 13 of 14 OSHA PSM elements and the FDA cGMP requirements (i.e. Employee Participation, Process Safety Information, Process Hazard Analysis, Operating Procedures, Training, Contractors, Pre-start up Safety Review, Mechanical Integrity, Hot Work Permit, Management of Change, Incident Investigations, Emergency Planning and Response and Compliance Audits). You can use most of the existing cGMP management systems for PSM implementation. It is easy to update the existing cGMP procedures to include specific PSM requirements instead of creating dual systems to handle these similar regulatory processes. PSM programs not only sustain compliance but also foster long-term sound business practices, reduce citations, and create value. The major objective of an effective PSM program is to prevent incidents and unwanted process upsets that could release hazardous materials into locations that could expose employees and others to serious hazards. An effective PSM program requires a systematic approach to evaluating the whole chemical or biological process similar to process validation but with a focus on potential safety issues.
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