One of the most overlooked sections in FDA guidelines is the definition section. It is important for everyone to know what is meant by each term used in the quality agreement; especially for contracts with non-U.S. citizens. Parts, the terminology can be very different. Add abbreviations and acronyms and define documents – one person`s batch record is another person`s data sheet. Define “subcontracting” and if and when it is acceptable. In November 2016, the FDA issued new industry guidelines titled Contract Manufacturing Arrangements for Drugs: Quality Agreements. This forecast is timely given the rise of the virtual biotech company in the development landscape. Most development programs now include support from at least one contract service provider (CSP) for services ranging from early development contract research to commercial manufacturing and analytical support. To learn how to optimize the coordination of quality agreements and other contract manufacturing functions with digital tools, read the trend letter “3 Ways Contract Manufacturing Organizations Are Turning to Digital Technology to Improve Collaboration.” A reasonably detailed quality agreement can help avoid assumptions that lead to compliance errors.
However, while a quality agreement defines the specific quality parameters of a project and which parties are responsible for their execution, the level of detail varies depending on the development phase of the project. At the very least, a quality agreement should delineate the obligations and responsibilities of each party in the following basic elements mentioned in the guidelines: Quality assurance with the contribution of manufacturing and laboratory personnel from both parties should prepare the agreement. The quality assurance functions 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 FDA encourages parties engaged in contract manufacturing to implement quality management practices. This guide builds on the principles and recommendations of quality risk management set out in the ICH Guidelines to illustrate key points in the development and implementation of quality agreements that describe and support contract manufacturing agreements. The FDA`s current position on quality agreements is set out in the “Contract Manufacturing Agreements for Drugs: Quality Agreements” guidelines published in 2016. The guidelines explicitly state that manufacturing activities are the most important element of a quality agreement. It highlights the seven most critical areas that should be addressed in a quality agreement and their specific impact on each area in terms of quality and change control. Quality agreements between suppliers and suppliers define the conditions relating to the quality of materials or services delivered to a production facility and used in the products or in the manufacture of the products.
Quality of service agreements define the conditions relating to the quality of services provided to a production facility used in the manufacture of products. To be clear to our readers, the original FDA statement and the statement implicit in the final guidelines are correct: there are no legal or regulatory requirements for a quality agreement between owners and contractual entities. That being said, we have seen a significant increase in the number of clients seeking help in drafting and negotiating quality agreements between many types of parties – it is clear that the use of quality agreements is becoming both industry standard practice and useful for clarifying specific roles and responsibilities between parties. Such agreements can have both tangible and intangible benefits for all parties throughout the duration of the relationship. On the other hand, the new guidelines give a general overview of the areas that should be included in a quality agreement. It contains sections on the following elements related to manufacturing activities: If a separate contract laboratory is involved, all relevant roles and responsibilities must be defined. The quality agreement should explicitly state what data will be shared and how it will be disseminated. And in ICH Q10, 2.7, “Does the pharmaceutical quality system, including the management tasks described in this section, extend to the monitoring and review of outsourced activities? The quality responsibilities of the procuring entity and the contractor should be defined in a written agreement. An effective quality agreement specifies the specific sites on which the contracting plant will carry out production operations, including the specific services to be provided at each site. Another major problem with the guidelines is their lack of specificity. The discussion on the applicability of the ICH Q7, Q9 and Q10 international best practice standards tends to remain at a high level, rather than highlighting the key elements of the international guidelines that need to be addressed. .