2014 Coursera Partners' Conference
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Gcp Quality Agreement

The big question is: Why should the Agency provide a guide that only deals with commercial manufacturing? The role of the order manufacturer has grown over the past decade and has expanded to everything from API design to clinical logistics and pharmacovigilance. Commercial manufacturing is the relationship with which the biopharmaceutical industry has the most practical experience and the content and application of the quality agreement are well understood between the owners and the CMO. It is strange that the FDA has chosen to limit the scope of the guidelines to the commercial component when the main challenges for the industry are before commercial manufacturing. Quality agreements should not be used to “delegate legal or regulatory obligations to comply with CGMP.” Regulators outline five specific sections that, in “clear language,” should be included in a typical quality agreement: the FDA`s current position on quality agreements is outlined in the “Contract Manufacturing Arrangements for Drugs: Quality Agreements” guidelines published in 2016. The guidelines expressly state that production activities are the most important element of a quality agreement. It focuses on the seven most important areas that should be addressed in a quality agreement and their specific impact on the quality and control of change. The methods of guaranteeing and quality control of the study should be proportionate to the risks inherent in the study and the importance of the information collected. The proponent should ensure that all aspects of the study are operational and avoid complexity, procedures and unnecessary data collection. Protocols, case report forms and other operational documents must be clear, concise and consistent. 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.

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