This Is Framingham

This Is Framingham
Life in the ‘ham

What Are Quality Agreements

April 14th, 2021

Robert Iser, Vice President of PAREXEL Consulting, discussed with Pharmaceutical Technology Europe the role of quality agreements in outsourcing. In the current context of virtual enterprises and the development of outsourced medicines, it is important to properly monitor and monitor supervisory authorities. In addition, when the 2016 NACHtrags ICH/GCP E-6 (R2) is published, sponsors are required to prove that there is adequate oversight of the CROs provider, including those attributed by the cro (s) sponsor to another party. A quality agreement is the perfect tool for sketching out responsibilities and expectations. A quality agreement in the context of pharmaceutical development is an agreement negotiated and concluded between the quality services of a sponsor (pharmaceutical company) and their suppliers (CROs, etc.). It aims to define responsible responsibilities in the area of quality and to contribute to the development of safe products. Contractors inevitably have problems and quality agreements ensure that they are dealt with quickly and systematically. According to the FDA, a quality agreement is a comprehensive written agreement that defines and defines the obligations and responsibilities of the quality units of each of the drugs subject to the GMP order (1). The FDA notes that a quality agreement is not a commercial agreement covering the terms of a contract, but is prepared by quality staff and focuses solely on the quality of laboratory service provided. Whenever a contractor or ORGANISATION is used, including agreements between different departments of the same company, regardless of the physical location of the parties involved, a quality agreement should be reached. The agreement should cover all aspects of the project affecting the identity, quality, safety, efficiency and purity of a product.

Items that may affect the contractor`s or client`s compliance status should also be included. An effective quality agreement identifies specific sites where the contracting entity performs manufacturing operations, including specific services to be provided on each site. A quality agreement is a comprehensive document that describes both the specific quality parameters of a project and the part responsible for executing those parameters. The degree of detail of a quality agreement will vary depending on the development phase of the project. To avoid misunderstanding, a glossary that defines keywords, acronyms and abbreviations is essential. It is essential that everyone knows what is meant by any term used in the quality agreement. This is especially true when contracts with non-U.S. companies. terminology can be very different. Make sure you clearly define all referenced documents.

These agreements set deadlines and define accountability and responsibility. They complement contractual obligations. Not only are they useful for compliance with GCP compliance, but they are also commercial and can eventually save the sponsor time and money. Quality agreements are not only good business practices, but also regulatory requirements. ICH Industry Guide Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients recommends that owners evaluate contract facilities to ensure that contract sites meet CGMP for certain operations. Written agreements should also set out considerations relating to subcontracting. They should describe how changes to processes, equipment, methods and specifications are managed and allow the owner to verify the owner`s compliance with CGMP. The scope of the quality agreement should include several compliance activities, such as qualification, calibration and maintenance of analytical tools and manufacturing equipment; Validation of computer systems, analysis methods and manufacturing processes; The specifications used to pass or fail to pass analytical tests Processing, storing and preparing; Receiving, analyzing and communicating samples Collecting and managing laboratory records From

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