Customer Quality Agreements
There are regulatory requirements for quality agreements. While this is not currently required by U.S. SMPs for pharmaceuticals, it is very likely that they will be soon. In 2016, the FDA released the guidance document «Contract Manufacturing Arrangements for Drugs: Quality Agreements.» Adding a quality agreement requirement to 21 CFR 211 would bring U.S. PPPs into compliance with European Union (EU) GMPs and FDA-accepted ICH guidelines (see below). FDA investigators discovered that a contract production plant had delivered drugs without an expiration date to the United States. In response to FDA 483`s comments, the company said, «As we understand, our customers are testing to confirm stability and expiration date.» The company also responded that it has contacted its customers to confirm the responsibilities and expiration date of the drugs over the counter. The FDA put the company on the import alert and sent a warning letter to the owner with a courtesy copy. In this example, the contractual facility made a bad assumption. This shows why all parties need to be aware of their roles and responsibilities in order to ensure that adulterated products are not marketed.
Neither owners nor contractual entities can enter into contracts around CGMP. The FDA recommends that owners and contract entities use quality agreements to ensure that both parties understand and document the steps they will take to ensure compliance with CGMP. In the absence of a well-developed quality agreement, the quality of products manufactured for the account may be compromised and patient safety at risk. It is only in the last ten years that pharmaceutical quality agreements in the United States have become a practical and enforceable document that forms the basis of a productive CGMP relationship. This improvement is largely due to the guidelines of the FDA and European regulators on this subject (see the draft FDA guidelines «Contract Manufacturing Arrangements for Drugs: Quality Agreements» and EU cGMP Chapter 7). In a broad sense, the objective of a quality agreement is to clearly define, define and delimit the responsibilities of the respective SAQ services vis-à-vis the CMO and its client in order to clearly communicate the responsibilities of each party, with the ultimate goal of ensuring patient safety and compliance with the rules. . .