Although the FDA has not yet specifically requested, it is clear that current industry practices expect both a quality agreement and a supply agreement to be present in a manufacturing relationship. This predictive practice merely implements in writing the expectations that the parties already have and more clearly defines the responsibilities that, at present, may be misplaced or misunderstood. For both an auditor and the FDA, the presence of these documents shows proactive thinking and a company`s deliberate efforts to address responsibilities rather than simply ignoring them, giving the FDA a “good” impression, essential to passing the exam. Although the industry has prospered for years without these documents, it is clear that for future growth and sustainability, a quality agreement and delivery contract will be required for successful business relationships. Although quality agreements are not required at this time, the FDA has proposed on its website a guide for the development of a quality agreement. A careful reading of the warning letters issued by the FDA shows that quality agreements are becoming a fundamental requirement throughout the industry. While this example is addressed to the pharmaceutical industry, this excerpt from a 2011 FDA warning letter states: “… In particular, your company has not entered into a quality agreement with the manufacturer… responsibilities between the xxx company and the contractor are not clearly defined.
In addition, a similar observation was made about your failure to enter into a quality agreement with your drug manufacturer, … Again, although not yet necessary for our industry, historically, the FDA has produced these documents as an official “look” in the agency`s thinking. Cautious dietary supplement companies should work to design programs in light of these proposals, because the key letter in cGMP is the “c” for “current” thinking. In almost all cases of outsourcing of BMP`s activities, there will also be a trade agreement covering outsourced activities, such as a “manufacturing and procurement agreement,” for example.B. This trade agreement is generally developed by legal and commercial development staff and does not go into detail to comply with the principles of the GMP. The scope of the quality agreement should include several compliance activities, such as qualification, calibration and maintenance of analytical tools and manufacturing equipment; Validation of computer systems, analysis methods and manufacturing processes; The specifications used to pass or fail to pass analytical tests Processing, storing and preparing; Receiving, analyzing and communicating samples Collecting and managing laboratory records Gap management and change control. The agreement should clearly define routine, escalation and emergencies and how they will be treated. The agreement must also define what happens in the event of disputes that may be raised by both parties and document the mechanism for the prompt and effective resolution of disputes. Quality assurance should prepare the agreement with manufacturing and laboratory staff on both sides.
The functions of the SQ of both parties should review and approve the quality agreement. Nothing should be taken for granted. Each party must review the quality agreement to ensure that its requirements are taken into account. The ICH`s industry guide Q10 Pharmaceutical Quality System recommends that the owner, as a member of a pharmaceutical-grade system, ultimately be responsible for ensuring that “processes are in place to ensure control of outsourced activities and the quality of materials purchased.” It indicates that these processes should include risk quality management and critical activities, such as. B: The guidelines invite homeowners to verify and approve most changes before being implemented.