By defining a clear technical agreement, both sides know who is responsible for what, thus avoiding conflicts and having defined a clear path of escalation. When inspecting the contract site by the MHRA or FDA, the main question for inspectors is how the parties share responsibility, communicate and confirm GMP compliance. With a well-scripted technical agreement, the subcontractor has a ready-made answer to the investigator. Therefore, it is important to learn how to create a technical agreement on GMP. #Quality agreements can save a lot of time and money for a #lifescience company by avoiding misunderstandings, but only if the agreements are timely and thorough and have input from all stakeholders, says @MCMasterControl bit.ly/2DwrlEC Usually, there are only two parties to a quality agreement; these are defined as the customer (i.e. the pharmaceutical company or sponsor) and the contractor (contract laboratory) in accordance with EU GMP (2). Alternatively, the FDA refers to the “owner” and the “contractual entity” (1). Whatever names are used, there are usually two parties involved in a quality agreement, unless you are the Marx brothers (the party of the first part, the party of the second part.. the party of the 10th part and so on) (9). 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. Quality agreements should be created by the quality assurance functions of both parties with the participation of the relevant operating personnel, such as.
B manufacturing and laboratory personnel. They must be approved by the quality assurance function of both parties and the operations department of both parties. The legal department may or may not be involved in the quality agreement. The participation of the Legal Service in the preparatory phase would help to ensure the consistency of the quality agreement with the supply agreement; However, this may delay the implementation of the quality agreement if the legal service wishes to add unnecessary legal wording that has no place in the quality agreement. 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 the FDA`s 2016 guidelines on contract manufacturing agreements for drugs limited to human, veterinary, and biologic drugs. While these are specifically pharmaceuticals, biologics and veterinary drugs, others, including device manufacturers, can refer to them for advice and best practices. Figure 1 shows the compressed requirements of Chapter 7 of the EU GMP with regard to the customer or owner and the contractor or contracting entity to carry out the work. The responsibilities of the owner are indicated on the left side of the figure and those of the contracting institution on the right side of the diagram. The content of the contract or quality agreement is shown at the bottom of the figure. These points will be discussed later in this column.
What is a quality agreement? This term is not found in the Federal Food, Drug and Cosmetics Act (FD&C Act) or regulations. This can be seen as a conventional meeting of the Spirit. If both agreements contain provisions on the same subject matter, these are carefully considered if one of the agreements is subsequently amended. In the simplest case, the purpose of a quality agreement is to control the expectations of both parties involved from the point of view of the quality of work and compliance with the applicable regulations. Under the FDA, there is no explicit regulation in 21 CFR 211(8), but it is a regulatory expectation as stated in the guidelines (1). Arvilla Trag, RAC, a consultant at BioProcess Technology Consultants, has 27 years of experience in the development of 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 writing all submissions in the United States. FDA CBER and CVM as well as USDA APHIS, SOP and archive maintenance, and cooperation 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. These agreements set timelines and establish responsibility and accountability. They complement the contractual obligations. Not only do they have regulatory sense to ensure compliance with PCBs, but they also make economic sense and can potentially save the developer time and money.
What can be excluded from a quality agreement is also worth mentioning. Some elements that should never be included in a quality agreement include: The FDA recommends that the quality agreement include the following provisions: The scope of the quality agreement should include several compliance activities, such as. B, the qualification, calibration and maintenance of analytical and manufacturing equipment; validation of computer systems, analytical procedures and manufacturing processes; specifications for the success or failure of analytical tests; handling, storage and preparation of deliveries; receipt, analysis and communication of samples; collection and management of laboratory records; and variance management and change control. “They tell you what you`re going to do, and you might say, `It`s cute, but you know what? I have my own obligations. I have obligations with the FDA,” or even obligations from the DEA or the government, Minsk pointed out. 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. . .