In a recent post by FDA, Janet Woodcock – the primary reason for drug shortages are because of either manufacturing or quality related issues.
All drug manufacturers that sell their medications in the United States must adhere to the FDA’s Current Good Manufacturing Practice (CGMP) requirements. Adherence to CGMP requirements is intended to make sure the drug itself is of adequate quality.
We all know the SISPQ – Safety, Identity, Strength, Purity and Quality. But what about Yield?
Janet Woodcock commented – But there’s another element to quality in manufacturing — the ability to reliably make the product in sufficient quantities and with sufficient speed to ensure that supply consistently meets demand over sustained periods of time. This is especially true in the pharmaceutical industry, where the product is often life-sustaining — and ongoing access is critical. This implies that yes, manufacturing reliability thus Yield is a quality consideration in addition to a business related one.
If we go back to the 2011 FDA Process Validation guidance – the purpose of Stage 2 , second element is to demonstrate that the actual facility, utilities, equipment (each now qualified), and the trained personnel with the commercial manufacturing process, control procedures, and components to produce commercial batches. A successful PPQ will confirm the process design and demonstrate that the commercial manufacturing process performs as expected [bold added].
if during stage 3 continued process verification we identify new sources of variation, or existing sources that were not properly evaluated during stage 2 – is the process operating in a state of control, reliably manufacturing the product at the appropriate yield and SISPQ? Most probably not.
If we could reduce or eliminate the manufacturing and quality related issues most probably the number of drugs on the shortage list would be significantly reduced.