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- 04/15/2019

SafeBridge® Potent Compound Safety Certification – Assessing Capabilities for Safe Manufacture of Potent APIs/Products

Chimica Oggi-Chemistry Today

The SafeBridge® Potent Compound Safety Certification program was developed to assess whether a company has an effective, systematic and demonstrable approach to the safe handling of potent compounds.  Experts in industrial hygiene, toxicology and safety perform an independent assessment of a company’s performance in safely handling potent compounds, intermediates and novel compounds.  This involves measuring performance in key areas including containment and controls, as well as support programs, all of which must be passed to gain SafeBridge Certification. Contract Manufacturing Organizations (CMOs) have found this program increases their visibility in the marketplace and is recognized internationally as a benchmark of potent compound safety competence. Drug innovators and “Big Pharma” companies regard the SafeBridge Certification as a valid indication of a CMO’s competency in potent compound health and safety. 

Areas assessed:

  • Program Management: The company’s commitment to proactive management and continuous improvement in potent compound safety is evaluated.  We look for appropriate skills being brought to bear (either internal or external resources) including industrial hygiene, safety, engineering, toxicology, analytical chemistry and occupational medicine.  We look for effective management of potent compound safety, goals and objectives for the management team, defined budget for improvements, involvement of the EH&S function in related business decisions and change control, and development and implementation of a strategic plan. 
  • Hazard Identification and Evaluation:  The company is evaluated on its ability to bring the appropriate occupational health assessment tools for the proper categorization (or banding) and limit setting of APIs; analytical chemistry to develop sensitive monitoring methods to analyse samples; industrial hygiene to conduct air monitoring, interpret data and recommend exposure controls; and occupational medicine to establish a health surveillance program to identify potentially at-risk workers and identify the first signs and symptoms of occupational disease. 
  • Exposure Controls and Containment: This is the most important aspect of demonstrating overall safety management and therefore the most weighted criteria for SafeBridge Certification.  Both facility controls (airlocks, air pressurization scheme, gowning/degowning facilities, HVAC and filtration) and process controls (controls and containment around equipment) are evaluated.
  • Communication and Training.  We look to see that all persons who may come into contact with potent compounds are suitably trained, informed of the level of risk based on IH data and that SOPs are in place.
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