Quality agreements are required according to medical device regulations, 21 CFR 820.50 purchasing controls as well as various quality standards such as ISO. 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. A quality agreement is a document that defines both specific quality parameters for a project and the party responsible for executing those parameters. The degree of detail may vary depending on the stage of development of the project. Quality agreements are also defined in the ICH quality documents. ICH Q7, 16.12, „There should be a written and approved contract or formal agreement between a company and its contractors that specifies the responsibilities of PMPs, including quality measures, for each party.“ One of the many important details of quality agreements are time slots.
If a CMO wants a five-day processing period to verify a master batch (MBR) record, this may be helpful because no data is to be verified. However, if the CMO wants a five-day rotation to verify a batch production dataset (RPO), this is not reasonable in most cases. There is simply too much data to check to be able to do a thorough job in five days. A quality agreement clearly indicates what is expected of both parties and who will be responsible for almost all aspects of the project. In addition, specific aspects of project costs will be identified, which could result in time and money savings. With regard to quality management, the ICH states that if it designates quality units „independent of production,“ it means „guaranteeing impartial decisions regarding quality decisions in the organisational structure. The person in the quality unit responsible for the final decision — for example. B the decision to release the lots) should not be responsible for production activities.“ The ICH also states that product quality verification is „generally expected annually,“ although audit times can be adjusted on the basis of production and duration of the campaign, for reasons that are properly justified. „Even if there was no production during the audit period, quality control should be carried out in accordance with section [ICH Q7, section 2.50] and cover stability, returns, claims and recalls,“ the group said.