An effective quality agreement is written in a way that communicates each party`s responsibilities in a clear and concise manner, so that the reader can quickly and accurately determine to whom a particular responsibility is assigned. An ambiguous agreement is a recipe for a disaster that can result in a waste of time and money for both parties. CMOs must maintain a standard model that has been pre-approved by their legal services, with misunderstandings or disagreements in the wording developed prior to approval. Because each business/client relationship requires a level of adjustment to reflect agreed responsibilities, the matrix can collect this information to avoid major changes in the model. This will help reduce the time and money required for legal verification for each client. The guide describes NMPA`s current thinking on the definition, definition and documentation of the manufacturing activities of parties involved in the manufacture of contract drugs, subject to current GMP requirements and all applicable laws and regulations. In particular, the guide clarifies the difference between the contract manufacturing agreement and the quality agreement, defines the key elements of a quality agreement in the model agreement and specifies the distribution of the parties` responsibilities with respect to these manufacturing activities. As a general rule, a “Definitions” section should be part of all quality agreements. As long as each party does not have a clear and reciprocal understanding of the terminology used in the agreement, it is only a matter of time before communication problems arise that may compromise the cGMP compliance of outsourced activities.
In the broadest sense of the word, the objective of a quality agreement is to clearly define, define and delineate the responsibilities of the respective QS services of the CMO and its client, in order to clearly communicate the responsibilities of each party, with the ultimate aim of ensuring patient safety and compliance with legislation. Another advantage of implementing a clear and concise quality agreement is to create a more efficient and effective working relationship between CMO and clients. The guidelines stipulate that the CMO must scrupulously comply with all obligations under the Quality Assurance Contract, meet all GPF requirements and produce drugs strictly in accordance with national standards and procedures approved by the NMPA. In particular, the name, dosage, specifications, manufacturing process, source of raw materials and additives, packaging materials and containers in direct contact with medicines, packaging specifications, labels, instructions, certificate number of authorization, etc.