21/22 October 2020
The topics of supplier qualification and auditing are not new. They are part of the Pharmaceutical Quality System (PQS). Also in other industries these tasks are an indispensable part of supplier management and co-operation. It is therefore surprising that this still leads to observations in GMP inspections. This has now happened at a company in the USA which was inspected by the US Food and Drug Administration FDA. The FDA has now published a Warning Letter.
The inspected company Acella is working with a contract manufacturer (CMO), which was also inspected by FDA. Here, FDA made observations concerning their stability program and found several lots from a previous API supplier of Acella that exceeded 110.0% USP specification during release or stability testing. Acella subsequently agreed to voluntarily recall these lots. However, the FDA thought that these lots should have been identified at an earlier stage. FDA stated that Acella's "quality control unit failed to provide adequate oversight" of the CMO and that Acella "was responsible for auditing" the CMO to "ensure a stability program was appropriately implemented and followed".
In this Warning Letter, FDA further points out that companies are "responsible for the quality" of drugs "regardless of agreements in place" with contract facilities. Companies are "required to ensure that drugs are made in accordance with section 501(a)(2)(B) of the FD&C Act to ensure safety, identity, strength, quality, and purity" and refers to FDA's guidance document Contract Manufacturing Arrangements for Drugs: Quality Agreements.