Whenever a contractor is used – from a low-wage manufacturing organization to a test lab – there should be a quality agreement. The issues to be addressed in a quality agreement include all aspects of a project that affect the identity, quality, safety, efficiency and purity of a product. It also covers areas that may affect the contractor`s or client`s compliance status. One of the most overlooked sections of the FDA`s #quality agreement guidelines is the definition section. It is important to know what any term means, especially when contracts with non-American supplier parties, says @MCMasterControl bit.ly/2DwrlEC Each party will implement, implement and perform operational procedures and controls for sampling, stability and other tests of its connection, and for validation, documentation and release of its link and other quality assurance and quality control procedures, as required in specifications, cGMP and quality clinical agreement. A formal corporate guidelines document should clearly state the types of providers and services for which a quality agreement is required. Whenever an OCM/contractor uses, there should be a quality agreement. A quality agreement should exist with all suppliers of critical materials and is also recommended for suppliers of large quantities, for example. B methylcellulose for capsules, column resins, etc. And in JE Q10, 2.7, “The pharmaceutical quality system, including the management responsibilities described in this section, covers monitoring and verification of outsourced activities… Responsibilities for the quality of the donor`s and contractor`s activities should be defined in a written agreement. One of the most overlooked sections of the FDA guide is the definition section. It is essential that everyone knows what is meant by any term used in the quality agreement; especially for contracts with non-U.S. companies, the terminology can be very different.
Insert abbreviations and acronyms and set documents – one person`s data sheet is another person`s data sheet. Define “outsourcing” and if and when it is acceptable. The collaborative approach to the development of a quality agreement creates a sense of ownership of the project by all participants, with the common goal of carrying out a quality study. This will ensure a “win-win” situation in which both parties will be required to discharge their responsibilities and focus on unilateral errors made by the supplier if they do not meet sponsorship standards.