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. 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 each party`s obligations and responsibilities into the following building blocks listed in the guidelines: According to the FDA, a quality agreement is a comprehensive written agreement between the parties involved in contract manufacturing that defines and determines each party`s manufacturing activities with respect to GMP compliance. The agreement should clearly indicate whether the owner or the procuring entity (or both) carries out certain GMP activities. (1) The speed of innovation and competition in the life sciences are 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). A section of the agreement should deal with specific considerations on individual products. It is also worth clarifying how owners share knowledge, such as. B information on product and process development, with contractual facilities to ensure that manufacturing complies with GMP. A quality agreement should specify which party defines component specifications and which part defines the processes for auditing, qualifying and monitoring component suppliers. It should also be specified who will carry out the tests or sampling necessary to comply with GMP. 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.” The FDA does not have specific guidelines for quality agreements between medical device companies and the CMOs that provide services to them. However, the FDA guidelines state that quality agreements should cover activities covered by Part 820 of the 21 CFR, the Quality System Regulation (QSR) for medical device companies, “where applicable.” Given the inclusion of Part 820 in the Guidelines, a quality agreement between a medical device company and a CMO should address the following aspects to varying degrees, depending on the nature of the relationship between the two parties and the products and services concerned: In the view of the FDA, any activity that is not documented may just as well not have taken place. A quality agreement gives the contractual facility and the owner the opportunity to set expectations as to who reviews and approves quality documents.
It shall describe protocols for modifying standard operating procedures (SOPs), manufacturing records, specifications, validation documentation and other essential documents related to the goods or services provided by the procuring entity. The role of both parties in creating and updating original GMP-compliant documents or actual copies should be clarified. The agreement should also specify how these records are to be readily available for inspection. It is beneficial to include a statement that electronic records are stored in accordance with GMP and kept in a recoverable state for the required registration periods specified in applicable regulations in accordance with FDA requirements. 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. The guidelines require owners to review and approve most changes before they are implemented. However, in some circumstances, contractors may make changes without notifying the owner. A quality agreement should define how all these changes are made and managed. 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. 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. In addition to detailing each of these facets, it is advisable to also include formalized plans for communication, file availability and audits. .