Drug Potency – The formulated active strength of a drug product (e.g., 25mg, 50mg) that is designed to be efficacious in treating an illness or other medical condition.

Why it Matters – Drug products must be formulated to a specified potency and this strength is included on product labeling. Physicians, pharmacists, nurses and patients rely on product labeling to confirm that the drug in the container is the correct potency needed to treat the disease or illness. 

Case Study – A sponsor contacted a Contract Development and Manufacturing Organization (CDMO) to develop, manufacture and test capsules at three different potencies (25mg, 50mg, and 75mg). Formulations scientists developed several different prototypes that utilized different excipients.  The sponsor and the scientist agreed on the prototype that would be manufactured and the project was handed over to the manufacturing team to draft batch records.  A few weeks later, the CDMO began manufacturing the 25mg strength using the approved batch record.  The active ingredient was combined with the excipients, mixed in a v-shell blender, and samples were taken from the blender and tested for blend uniformity (e.g., homogeneity of the active ingredient and excipient mixture).  Each sample failed to meet the potency specification.  At first, the CDMO thought insufficient blending was the cause of the problem but additional mixing, sampling and testing produced very similar results.  The formulation scientist who developed the prototypes was called in to troubleshoot the issue.  After careful review of the batch record, he discovered that the batch record specified the incorrect quantity of active ingredient which produced a potency that was only 20mg. 

Discover how Eastlake Quality Consulting can assist with technology transfers and batch record review.