Corden’s Boulder, Colorado plant was deemed competent and proficient in the safe handling of highly potent APIs (HPAPIs) and compounds of unknown toxicity and potency following a 60-element review of health and safety programmes and procedures undertaken by occupational health and safety consulting firm, SafeBridge.
Managing the safety of HPAPIs has a number of benefits for a company beyond just obtaining certification, SafeBridge Europe’s Managing Director Justin Mason-Home told in-Pharmatechnologist.com. On top of fulfilling health and safety regulations the number one reason, he said, was ensuring workers were safe and content when handling such toxic compounds, citing an example of one unnamed company whose staff refused to work due to fear of cytotoxic contamination.
Therefore “within the [certification] programme, we are looking for facility features and process controls (engineering) and the integrated pro-active health and safety programme elements of industrial hygiene and toxicology to be in place, plus the management systems to support them,” Mason-Home said.
“These things should be part of the way the subject company does business,” he continued. “Once SafeBridge Certification is achieved, we are looking for these systems to be maintained and, if necessary, improved.”
The facility is the latest of thirteen sites worldwide to receive such status and be actively part of the programme, according to Mason-Home, the others being:
SAFC in Madison, WI (two sites); SAFC in St. Louis, MO; Ferro-Pfanstiehl in Waukegan, IL; DSM Pharmaceuticals in Greenville, NC; Novasep in Le Mans, FR; ScinoPharm in Tainan, Taiwan; Excella in Feucht, Germany (both OSD and API facilities); AMRI in Rensselaer, NY; Baxter Oncology in Halle and Bielefeld, Germany (two sites).
Certification not accreditation
The certification programme is directly involved in the health and safety aspect of manufacturing, rather than elements of the drugmaking process related to the quality of the product or cGMP which is accredited by regulatory bodies such as the US Food and Drug Administration (FDA) or European Medicines Agency (EMA).
Whilst Mason-Home told us there was a slight crossover with the drug agencies regarding cross-contamination management, the certification is more similar in vein to the International Organization for Standardization’s (ISO) ideals, though due to the nature of the ingredients, on a much smaller scale.
Within other industries, hazardous materials are regulated by health and safety regulations and risk assessments. However, for the thousands of hazardous APIs made today only paracetamol and warfarin are regulated in such a way due to the higher number of people involved in the manufacturer of these substances, Mason-Home said.
Furthermore HPAPIs are one of the most hazardous and difficult to test, he continued, even more so than radioactive material. For example, in a nuclear facility it is easy to gauge whether radiation levels are too high and governments are able to set limits.
For potent compounds there is much higher uncertainty in a work environment due to being unable to monitor such substances in realtime, he continued, and furthermore there are no detectors on the market. “The first we might know is if people [at the plant] fall ill.”
As for rivals, there are other companies working in a similar field to SafeBridge but Mason-Home told us “none have the range, depth or pharma and biopharma experience that SafeBridge has.”