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.