The World Highly Potent Active Pharmaceutical Ingredient (HPAPI) Summit was held earlier this week and Dean M. Calhoun, CIH of Affygility Solutions, gave a presentation on Environmental, Health and Safety (EHS) Auditing of Facilities Handling Highly Active Potent Compounds. In this presentation (see the Youtube video below of the presentation), Dean covered the following areas:
Why Are You Conducting an Environmental, Health and Safety Audit?
- The importance of determining the “why” you are auditing a facility handling highly potent active pharmaceutical ingredients (API)s. The reasons “why” can include regulatory compliance, risk reduction, sharing best management practices, management accountability, contract manufacturing organization (CMO)/contract research organization (CRO) verification to ensure that a potent compound safety program is in place, management systems verification (Pharmaceutical Supply Chain Initiative, ISO 14001 certification, ISO 18001 certification, other types of certifications), acquisitions/divestures, and more.
- Planning for the Environmental, Health and Safety Audit
- Why obtaining senior management support prior to conducting any environmental, health and safety audit is critical
- Understanding the various legal considerations prior to performing environmental, health and safety auditing potent compound handling facilities
- Considerations for selecting and training your EHS audit team
- Pre-audit items, such as audit protocols and checklists, that should be planned
- Conducting an opening conference
- Common observations and findings at facilities handling highly active potent compounds
- Write a draft environmental, health and safety audit report
- Why follow-up to the audit findings, including developing and implementing a corrective action plan and corrective action tracking is the most critical part of any environmental, health and safety audit
- Summary of key points
If you have questions or need additional information about environmental, health and safety auditing of facilities handing highly active potent compounds, potent compound safety, potent compound categorization, or industrial hygiene please contact Affygility Solutions