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 supplier`s quality agreement is a comprehensive written agreement (usually supplemented by a checklist) that defines and establishes the quality and good manufacturing practice (GMP) obligations of the design owner and the supplier. A quality agreement is an important part of a supplier qualification program, but it does not replace supplier qualification processes (including on-demand audits) or understanding of the supplier, its processes and capabilities. A quality contract must not contain commercial or liability clauses that should be dealt with exclusively in a supply contract. Quality assurance with input from 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 quality agreement must be specific to specific products.
One size fits all is not for everyone. Often, companies will ask for a model agreement, or companies will often have their own model agreement, Minks said. It`s good to start with that, but you don`t end with a pattern of agreement. While this contributes to profitability, there is no reason to reinvent the wheel. Every project is different. Once both parties are satisfied with the agreement, ask your legal team to conduct a full review. Your legal team will review the agreement and ensure that all the necessary legal wording is in place and that the agreement meets the organization`s requirements. There are four types of quality agreements: manufacturing, supplier, supplier and service quality agreements, each tailored to the relevant aspects of each type of relationship. A quality agreement ensures that you and your material supplier or contracted manufacturer are on the same page by laying the foundation for quality and communication standards. It plays a crucial role in avoiding fines, which can amount to tens of millions of dollars for some medical device companies, and in providing the best possible product.
However, the FDA sets out many requirements in its quality system regulation that a quality agreement must cover. Even if the FDA doesn`t explicitly require a quality agreement, creating one can still help them meet other requirements. There is a misconception that quality agreements are only required for the use of collective management organisations operating in a different regulatory environment. This is not the case – any outsourcing contract should have an associated quality agreement, including agreements between different departments of the same company, regardless of the physical location of one of the parties involved. Once your quality agreement is finalized, both parties can begin the real process of collaborating and implementing the agreement. Duration of the agreement: In simple terms, the quality agreement must have clear start and end dates and must set out all the conditions that would lead to a termination of the contract. ”It`s not that the FDA said, `They violated GMP because there was no quality agreement. It`s not so black and white. What the FDA will say is, ”There was a violation of the law. And if you had a quality deal, that might not have happened.
Or: ”They had a quality agreement and didn`t follow it. Or the FDA could name a company because it doesn`t have an effective quality control unit if the quality of the product has been negatively affected. ”What is a quality agreement? This term is not found in the Federal Food, Drugs and Cosmetics Act (FD&C Act) or regulations. This can be seen as a conventional meeting of the Spirit. 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). Quality agreements and agreements with suppliers are essential for the placing on the market and maintenance of a medical device. In this context, the two define different requirements in the relationship between the manufacturer and the supplier. Quality agreements help both parties in the overall contract analysis process. They define, establish and document the roles and responsibilities of all parties involved in the process. Quality agreements allow each party to define its expectations and rules for projects and to ensure that the quality characteristics of both parties match and that each party receives effective quality services and products. 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. Another reason to have a quality agreement is to ensure that the parties, whether within or outside an organization, are literally and figuratively on the same page and in agreement. Therefore, in this captivating episode of ”Focus on Quality, we discuss the quality agreements why they are important for laboratories and what they should include for contract analysis. The principles discussed here should also apply to laboratories accredited by the International Organization for Standardization (ISO) 17025, as well as to third-party service providers for regulated laboratories and quality laboratories. The agreement should clearly define routine, escalation and emergency cases and how they will be handled. The agreement should also define what happens in the event of disputes that may be raised by both parties and should document the mechanism for the early and effective resolution of disputes. A quality agreement serves as the basis for any productive partnership between your company and a supplier or manufacturer. You will also need the best quality management software to help you carry out the various activities of your quality contract and streamline communication between your entire team and your supplier or subcontractor. Terms and Conditions: Use this section to determine working hours and any termination clauses and to determine who should be contacted regarding anything outside of CAPA and the quality issues described in the quality agreement.
Privacy: Your supplier may be aware of information about your product or process that is not intended for the public, or at least not intended for the public at this time. Use this section of your agreement to make sure both parties know what can and cannot be shared with the public – or competitors. Whenever a contractor – from a contract manufacturing organization (CMO) to a testing laboratory – is deployed, a quality agreement must be concluded. The issues to be addressed in a quality agreement include all aspects of a project that affect the identity, quality, safety, efficacy and purity of a product. Also add aspects that may affect the compliance status of the contractor or customer. ”You and I decide to agree to do something, and I hope it will be in writing,” Minsk said. ”In this case, it`s a quality agreement. We decide to write who will be responsible for what, in particular to delegate the responsibility of ensuring compliance with current good manufacturing practices. According to the FDA, a quality agreement is a comprehensive written agreement that defines and establishes the obligations and responsibilities of the quality units of each of the parties involved in the contract manufacturing of GMP drugs (1). The FDA emphasizes that a quality agreement is not a commercial agreement that covers the commercial terms of a contract, but is prepared by quality personnel and focuses solely on the quality of the laboratory service provided. Quality agreements are specifically required by the EU and the FDA; If you`re operating in another region, it`s a good idea to implement a quality agreement, even if it`s not a regulatory requirement.
Quality agreements are required by medical device regulations, 21 CFR 820.50 purchase controls as well as various quality standards such as ISO. In addition, ICH Q7, the application of GMP to active pharmaceutical ingredients (APIs), includes Section 16 entitled ”Contract Manufacturing (including Laboratories)”. This document has been published by the FDA (6) as an ”Industry Guide” and constitutes Part 2 of the EU GMP (7). Article 16 states: ”There should be a written and approved contract or formal agreement between a company and its contractors detailing each party`s GMP responsibilities, including quality measures. As mentioned in the title of the chapter, the scope covers all contracted laboratories, which means that there must be a formal contract or agreement for the services provided to the API manufacturer or a third-party laboratory performing analyses on their behalf. .
