Would you like to know more about creating an effective quality agreement? Register for our free webinar: Supplier Qualification and Quality Management in FDA-Regulated Industries. This guide is intended to build on the principles and recommendations of quality risk management outlined in the following FDA guidelines: The FDA`s current position on quality agreements is set out in the “Drug Manufacturing Contracts: 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. In particular, the guidelines set out how contractors report manufacturing deviations and how these issues are investigated and resolved to maintain GMP compliance. Collaboration is critical to the success of any business partnership, so it`s important for owners and contractors to develop written and oral communication protocols. A quality agreement should define all manufacturing roles and activities and establish the appropriate contact personnel for each organization. Processes such as corrective and preventive measures (CAPA) and deviation management can cause disagreements, so the responsibilities associated with investigations and other processes involving the management of quality events must be clearly defined in the agreement. The guidelines also state that quality agreements regarding the release of products must be clear.
In short, the FDA expects “owners” to enter into written quality agreements with “contractual entities” in which the parties define and determine the roles and responsibilities of each party to ensure that drug substances and pharmaceuticals are manufactured in accordance with current good manufacturing practices. These quality agreements ideally determine which party carries out which activities and which party has primary responsibility for full compliance with the MPGC under section 501(a)(2)(B) of the Act and Parts 210, 211 and 600-680 of the C.F.R., as these regulations may apply to the product or substance in question. Another major problem with the guidelines is their lack of specificity. The discussion on the applicability of the ICH Q7, Q9 and Q10 International Standards of Best Practice tends to remain at a high level, rather than highlighting key elements of the international guidelines that need to be addressed. The ICH guidelines do an excellent job of formulating the problem, but they do not provide practical approaches to applying the concepts they teach. The new FDA guidelines would have been a great opportunity to provide examples of how these approaches should be articulated in the quality agreement. The guide – a more specific version of a May 2013 project – sets out the overall objective of a quality agreement: to define roles and responsibilities in manufacturing and to set expectations for communication between the parties. The FDA makes it clear that it does not believe that provisions incorporated into trade agreements such as master service agreements or supply agreements are sufficient to establish roles and responsibilities related to quality. The speed of innovation and competition in the life sciences is relentless. This is prompting more and more companies to adopt lean operating models that rely heavily on an ecosystem of contract manufacturing organizations (CMOs). As a result of this trend, the burden of meeting current Good Manufacturing Practices (GMP) guidelines is increasingly shared between companies that own products and the contract facilities on which they depend. A strong quality agreement is the first step in ensuring that both parties are accountable and working together to comply with regulations enforced by the U.S.
Food and Drug Administration (FDA). Deviations and corrective and preventive measures (CAPA) are other potential areas of discord. Deviations require the CMO and sponsor to understand the cause and impact of a QMS process or excursion. The primary responsibility for root cause investigations must be clearly stated in the quality agreement, as well as the question of when and how a drug sponsor may participate in an investigation. Often, large pharmaceutical and biotech companies have formalized investigative frameworks that need to be applied to gaps, while the CMO can enable alternative approaches. .
