OHSAS 18001 and Potent Compound Safety: Part IV

Hopefully by now, your company’s OHSAS 18001 and potent compound safety policy is nearing completion, but even if is not finalized – no worries! Plan on pressing ahead and start taking an inventory of all your legal and other requirements, and determining a standardized format for your procedures and other forms of documentation. You likely will create several levels of documentation and I would encourage you to engage in discussions with your quality people about their levels of documentation. However, you should decide early on if your OHSAS and potent compound documentation is integrated with your company’s product quality systems. This is an important decision, because if your OHSAS and potent compound safety systems are integrated within product quality systems, it could be unnecessarily subject those programs to examination by product quality regulatory agencies such as the FDA. There are advantages and disadvantages to having your OHSAS and potent compound safety program integrated in your product quality systems, and here at Affygility Solutions we would enjoy hearing everyone’s comments on their experiences with this issue. Please comment!

When developing procedures and other forms of documentation, it’s very important that every procedure have the following:

  1. An owner. This person will be responsible for knowing everything about this procedure and revising it when necessary.
  2. A unique procedure number or form number.
  3. A version or revision number.
  4. A creation date and/or revision date.
  5. A next review date.

The types of procedures that you will need for your OHSAS 18001 and potent compound safety program are numerous. These procedures can include, but are not limited to:

  1. New employee OHSAS and potent compound safety training.
  2. Classification and occupational toxicology review of new compounds.
  3. Control banding procedures.
  4. Medical surveillance.
  5. Respiratory protection.
  6. Process hazard reviews or risk assessments.
  7. Use/maintenance of engineering controls such as ventilated balance enclosures, isolators, glove boxes, etc.
  8. Containment verification and validation.
  9. Material safety data sheet authoring and maintenance. Be sure you’re ready for GHS.
  10. Hazard Communication and label/signage for areas where potent compounds are used, processed, or stored.
  11. Laboratory or chemical hygiene safety.
  12. Personal protective equipment hazard assessments.
  13. Lockout/tagout.
  14. Confined space entry.
  15. Electrical safety.
  16. Machine guarding.
  17. Waste disposal of active pharmaceutical ingredients and potent compounds.
  18. Accident/incident reporting and allegations of adverse exposure.
  19. Industrial hygiene monitoring, exposure assessments, and wipe sampling.
  20. OHSAS auditing.
  21. Emergency response. Note: It’s important that your emergency procedures specifically address potent compound safety. Most emergency response procedures that I have reviewed generically address “chemicals” but are often weak in potent compound spill procedures.

The above list is just a sampling of the types of procedures you’ll need. Have a meeting with your group, make a list of what you have and what you need. Start getting everything in a common format and everything up to date.


About Dean Calhoun

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Dean is the President and CEO of Affygility Solutions. Affygility Solutions provides environmental, health and safety software, potent compound safety, industrial hygiene, containment validation services to the pharmaceutical, biotechnology, and medical device industry. "Dean's Google+ Profile"

Affygility Solutions - provider of potent compound safety, webinars, and compliance management software