What Is A Quality Agreement Pharmaceutical
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. Iser: The European Commission has published a review of the European Union`s Good Manufacturing Practices (GMP) (Chapter 7) (2) with effect from 2013, in order to provide expectations for subprocessed activities regulated by GMP. The revised GMP guide contains many of the same themes contained in the FDA`s current industry guidelines, including the roles and responsibilities of the client (of the pharmaceutical company) and the contractor (the contracting body), the evaluation of an agency responsible for carrying out outsourced activities, the disclosure of information necessary to carry out the outsourced activities, the expectations for control of changes. Etc. A company wishing to enter into a quality agreement should use this guide. Iser: The FDA issued a definitive industry forecast for quality agreements with contract manufacturers in November 2016 (1). The guideline was developed in collaboration with the Centre for Drug Evaluation and Research (CDER), the Centre for Biologics Evaluation and Research (CBER), the Centre for Veterinary Medicine (CVM) and the Office of Regulatory Affairs (ORA) and outlines the FDA`s current thinking and expectations for quality agreements. It is strongly recommended that companies refer to these instructions when initiating a new quality agreement or when reviewing an existing quality agreement with a contractual body.
This section should have been at the heart of the guidelines, but it has only two paragraphs. One of the main challenges in using a CMO is to define how the quality units of the two organizations collaborate and interact with each other. While it is true that the pharmaceutical sponsor cannot delegate its responsibility for cGMP compliance, the complexity associated with the orientation of a drug sponsor`s (QMS) quality management system to a CMO is palpable. For example, person-in-the-Plant (PIP) is a relationship point where friction can occur between an OCM and a sponsor. The rights and rights of notification, frequency, access and communication are elements that should be clearly defined in a quality agreement. A CMO has multiple clients, and each PIP requires hosting and management, which adds an additional level of organizational management to the CMO`s operation. In almost all cases of outsourcing of BMP`s activities, there will also be a trade agreement covering outsourced activities, such as a «manufacturing and procurement agreement,» for example.B. This trade agreement is generally developed by legal and commercial development staff and does not go into detail to comply with the principles of the GMP.