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 such an agreement can still help you meet other requirements. Once your quality agreement is finalized, both parties can begin the real process of collaborating and implementing the agreement. Quality agreements between suppliers and suppliers define the quality conditions of materials or services that are delivered to a production facility and used in products or in the manufacture of products. Quality of service agreements define the quality conditions of the services provided to a production facility and used in the manufacture of products. 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. The above elements belong to the supply contract. The quality agreement should be a separate document from the supply contract, but may be incorporated by reference. Quality agreements and supply agreements are two very different documents. When created as a single document, the list of reviewers includes many people on either side of the fence who have no real reason or time to consider issues that have nothing to do with their area of expertise.
The FDA reminds industry that quality agreements must be available for review by the agency when the agency conducts inspections. The FDA regularly requests proof of a quality agreement or lack thereof. To reduce the risk of misunderstandings, a glossary that defines keywords and abbreviations is an essential part of a quality agreement. The FDA states in the guidelines through two hypothetical scenarios that both owners and contracted facilities are responsible for current GMP and regulatory compliance. A quality agreement does not relieve the parties of their legal or regulatory responsibilities. However, the application holder remains ultimately responsible for ensuring that its products are manufactured in accordance with the MPMC or the Quality Systems Regulations (QSR), even if the quality agreement delegates certain manufacturing activities to the contract facility. And in ICH Q10, 2.7, ”The pharmaceutical quality system, including the management responsibilities described in this section, extends 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. A quality agreement focuses solely on the FDA`s current Good Manufacturing Practices (GMPCs), which state that the overall goal is to ensure product quality, safety, and efficacy. A quality agreement aims to minimize problems, confusion, errors, and regulatory gaps – not necessarily to eliminate them, as it`s almost impossible trying to write things down in advance. That is one of the big goals. 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-compliant medicines (1). The FDA emphasizes that a quality agreement is not a commercial agreement that covers the commercial terms of a contract, but is created by quality staff and focuses solely on the quality of the laboratory service provided.
Examples of FDA application have occurred when a quality agreement was not followed or a problem arose because there was no agreement and gaps were created. Also note that the quality agreement must be separate or at least separable from the commercial contract, e.B a service contract or a supply contract. As mentioned earlier, the quality agreement can be reviewed by the FDA during an inspection. In addition, ICH Q7, the application of GMP to active pharmaceutical ingredients (APIs), includes Section 16 entitled ”Contract Manufacturing (including Laboratories)”. This document was published by the FDA as an ”Industry Guide” (6) 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 stated in the title of the chapter, the scope covers all contracted laboratories, which means that there must be a contract or formal agreement for the services provided to the API manufacturer or to a third-party laboratory performing analyses on its behalf. Conversely, a supply contract specifies how the supplier promises to deliver all specified goods or services over a certain period of time and at what cost. It also includes the buyer`s obligations as to when and how the goods are purchased.
The supply agreement helps to facilitate the management of companies working together, eliminate ambiguities and create the framework for ordering and delivering goods and services. Additional FDA Controls: In addition to design controls, you should also explain which labeling, production, process, and packaging controls your device should follow. As with design controls, you must clearly state in your agreement the steps your subcontractor must take to comply with the regulations. A formal corporate policy document should clearly state the types of suppliers and services that require a quality agreement. Whenever a CMO/contractor is deployed, there should be a quality agreement. There should be a quality agreement with all suppliers of critical materials and is also recommended for suppliers of large quantities, e.B methylcellulose for capsules, column resins, etc. The FDA recommends that the quality agreement include the following provisions: Process protocols: The quality agreement should include all protocols, e.B how to handle materials, or what documentation should be updated. A number of people from the quality function of both organisations will be involved in the negotiation and operation of a quality agreement. Typically, some of the roles involved could be Arvilla Trag, RAC, a consultant at BioProcess Technology Consultants, who has 27 years of experience in developing new drugs. As President and Senior Consultant of Midwest Consulting Services (MCS) from 1997 to 2016, she prepared dozens of INDs and several sections of Modules 3 and 2.3 for BLA.
In addition to detailed bid preparation, Trag has conducted more than 250 CGMP compliance audits of contract manufacturers and testing laboratories, conducted due diligence audits for mergers and acquisitions, created several quality manuals, and conducted a quality systems gap analysis. She has extensive experience in product types and has participated in more than two dozen product development programs, including monoclonal antibodies, vaccines, small molecules and combination products. Prior to founding MCS, Trag worked as Director of Regulatory Affairs at Biopure from 1994 to 1997, where she prepared the NADA CMC section for hemoglobin-based oxygen-carrying oxyglobin. Prior to joining Biopure, Trag was Responsible for Regulatory Affairs and Quality Assurance at Virogenetics, a vaccine research and development center, where she was responsible for drafting all submissions to the U.S. FDA`s CBER and CVM, as well as the USDA APHIS, SOP maintenance and archives, and collaboration with local regulators. Prior to her work in virogenetics, she spent six years as a laboratory technician in the Department of Neurotoxicology at NYSDOH, where she performed mammalian tissue cultures, primary tissue cultures, and IEF and 2D SDS PAGE gels. Trag graduated magna laude from the College of St. Rose in Albany, New York, with bachelor`s degrees in biology and chemistry and certified regulatory affairs (RAC) since 1994. 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 an important 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. A quality agreement is not just a set of legally binding rules. It is also an integral part of supplier management and facilitates the establishment of an employment relationship.
The process of creating a quality agreement makes this relationship clear: there is a misconception that quality agreements are only necessary for the use of health ocs 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. So what we`re discussing in this captivating issue of Focus on Quality is quality agreements, why they`re important for labs, and what they should include for contract analysis. .