Important elements in evaluating contract manufacturing organizations - Sponsored Whitepaper

It is a universal truth that research, development manufacture and formulation of potent active pharmaceutical ingredients (APIs) and products requires both “hardware” ( facilities, equipment and engineering controls) and “software” (programs, practices and procedures) to adequately protect personnel and the environment. When employing third party contracting organizations, there is a need to evaluate safe processing with the same rigor as other aspects of drug development, such as quality assurance. Elements needed by the third party contract manufacturing organization involve the recognition of the degree of hazard of the API or product, risk assessment and evaluation through industrial (or occupational) hygiene assessment of potential exposure to workers in the chemical plant, pharmaceutical plant or laboratory environment, and the application of appropriate and verified containment and control measures to maintain exposures below acceptable levels. Specific elements should include categorizing (or “banding”) the API based on inherent potency and toxicity, linking the category to safe handling practices and control strategies, developing Occupational Exposure Limits (OELs) and suitable industrial hygiene analytical methods, implementing engineering controls to meet the OEL with emphasis on containment at the source of emissions and verifying the degree of containment and control through industrial hygiene quantitative assessment. Drug innovators should evaluate and assess (either with internal staff or through an independent expert) whether these elements are in place as part of their overall process of qualifying third party contract manufacturing or R&D organizations. The consequences of not managing this aspect well can include potential for delay in speed to market, lost revenue for the drug innovator (and third party manufacturer), damage to the business relationship, decreased workforce confidence and potential liability.