{"id":10285,"date":"2024-03-18T10:11:35","date_gmt":"2024-03-18T09:11:35","guid":{"rendered":"https:\/\/www.sciencepharma.com\/blog\/a-quality-agreement\/"},"modified":"2024-07-23T10:02:42","modified_gmt":"2024-07-23T08:02:42","slug":"quality-agreement","status":"publish","type":"blog","link":"https:\/\/www.sciencepharma.com\/pl\/blog\/quality-agreement\/","title":{"rendered":"How to divide responsibilities in a GMP-related contract? A quality agreement is the answer"},"content":{"rendered":"

For any company operating in the pharmaceutical sector and involved in manufacturing and\/ or importing human and veterinary medicines, the Good Manufacturing Practice (GMP) is the closest thing to a holy book in the industry. It ensures that products are consistently produced and controlled according to quality standards, minimizing the risks involved in any pharmaceutical production. As such, it is essential for any company in the sector to adhere to GMP guidelines to guarantee the safety, efficacy, and quality of their products. The European Union GMP guidelines<\/a> refer several times to a term which at first may seem confusing to someone not familiar with the terminology specific to the pharmaceutical industry \u2013 a quality agreement. <\/em>What is hiding behind such an enigmatic TQA name? – a tool proven to be a valuable instrument while dealing with any GMP-related operations<\/strong>.<\/p>\n

In today’s blog article, we will discuss the topic of quality contracts in the pharmaceutical industry. You’ll learn why such agreements are crucial to ensuring the safety and effectiveness of medicines. We will also look at the important aspects of such contracts and what benefits they can bring to pharmaceutical companies. Are you curious? I invite you to read!<\/p>\n\n\n

What is a quality agreement?<\/strong><\/h2>\n\n\n

A Quality Agreement, or in other words, a technical agreement, or technical quality agreement (TQA), has been defined by the US Food and Drug Administration (FDA) as a \u201ccomprehensive written agreement between parties involved in the contract manufacturing of drugs<\/strong> that defines and establishes each party\u2019s manufacturing activities in terms of how each will comply with cGMP\u201d[1]<\/a>. A quality agreement identifies all relevant quality aspects and defines the roles and responsibilities of interested parties. As a general rule, a quality agreement should be placed between the entities involved in the outsourcing of even the tiniest bit of the medicinal products\u2019 manufacturing process. Such entities are usually either contract givers<\/strong> (commissioning a service, product, project or study) or contract acceptors<\/strong> (agreeing to provide a service, product, project or study according to the contract givers\u2019 specified requirements). Therefore, the quality agreements with the API Suppliers, Excipients Suppliers, Raw Material Suppliers, Packaging Material Suppliers, Contract Manufactures for Pharmaceuticals, Contract Laboratories, Distributors, Transportation Providers, Warehouses or IT Suppliers have to be concluded in accordance with Good Manufacturing Practices. Nevertheless, the need for conclusion of the quality agreement must be evaluated as part of the supplier qualification process.<\/p>\n

The quality agreements should be written in a manner ensuring full transparency<\/strong> \u2013 each role and responsibility, including communication processes and timelines should be fully clear and understood by each party \u2013 the contract giver and the acceptor. The value of a common understanding in the field of quality cannot be overemphasized, as it is crucial to protecting patients’ health. In order to fully conform to the current GMP (cGMP), there is no room for ambiguity \u2013 according to the EU GMP guidelines, the contract should describe clearly who undertakes each step of the outsourced activity<\/strong>[2]<\/a>.<\/p>\n\n\n

What falls within the scope of a quality agreement?<\/strong><\/h2>\n\n\n\n
\""Illustration<\/figure>\n\n\n

The purpose of a quality agreement is to explicitly assign specific GMP activities<\/strong> to particular parties thereto. In terms of the legal construction of the contract, according to the FDA\u2019s recommendations[3]<\/a>, a quality agreement should include at least the following sections:<\/p>\n