Individuals who need to know the content of the quality agreement to do their job should be included in the review of the agreement, including business development, project managers and legal projects (to ensure compliance with the delivery agreement). #Quality agreements can save a #lifescience company a lot of time and money by avoiding misunderstandings, but only if the agreements participate in a timely, thorough and on the part of all parties involved, @MCMasterControl bit.ly/2DwrlEC PTE: what mistakes do companies make in the development of quality agreements? Iser: It is important that a quality agreement between a pharmaceutical company and a contract agency clearly define the roles and responsibilities of CGMP`s activities. It is equally important, as the FDA guidelines state, “that quality agreements cannot be used to delegate legal or regulatory responsibilities for compliance with PMCs.” It is likely that the FDA would cite a company because it deviates from the expectations of the CGMP, because it respects an under-quality agreement that violates the principles of the BGP. Only in case you missed it above, the contract lab must generate complete data, such as the GMP request for all the work it does. This includes both the paper and electronic recordings I mentioned in a previous column entitled “Focusing on Quality” (10). Fda guidelines state that the quality agreement must document how the “immediate consultation” requirement is met by either the owner or the contract laboratory (1). Both types of data must be protected and managed during the data retention period. While quality agreements can cover the full spectrum of pharmaceutical development and manufacturing, we will focus on the laboratory for the purposes of this topic. As part of this discussion, the concept of a laboratory for a laboratory company will be applied to regulated analysis either during research and development (R-D) or in the manufacturing phases of a drug`s life, including cases where all manufacturing and testing is outsourced to a contract manufacturing organization (CMO), where all analysis is outsourced to a contract research organization (CRO) or test laboratory, or only specialized testing is outsourced by a company. Indeed, there are specific laboratory requirements that are discussed in FDA guidelines (1). Quality agreements should be developed by the quality assurance functions of both parties, with the participation of the operational staff involved, for example. B manufacturing and laboratory staff. They should be approved by the SQ function of both parties and by the operating department of both parties.
The legal division may or may not participate in the quality agreement. The inclusion of the legal division in the preparatory phase would help to ensure that the quality agreement is in line with the delivery agreement; It may, however, delay the performance of the quality contract if the legal department wishes to add unnecessary legal formulations that do not fall within the quality agreement. That`s why we`re discussing quality agreements in this exciting edition of Focus on Quality about why they are important to laboratories and what they should contain for contract analysis. The principles outlined here should also apply to laboratories accredited to the International Standards Organization (ISO) 17025, as well as service providers to regulated and quality-oriented laboratories.