In the past, there have been several cases of conflict and misunderstanding that have led to disruptions in relations between organizations. The main cause of these conflicts is the lack of understanding of quality agreements and its impact on regulatory levels when a product is delivered by a contract processor to a contract giver. These agreements will ensure that the choice of raw materials, components, processes and controls, testing, releases, quality, documentation and supply chain for high-quality medicines and biopharmaceuticals is not at any time compromised on good manufacturing practices (GMPs). According to the FDA, a quality agreement is a comprehensive written agreement between the parties involved in the manufacture of the contract, which defines and defines each party`s production activities with respect to CGMP compliance. The agreement should make it clear whether the owner or contracting body (or both) is engaged in certain CGMP activities. (1) A well-developed quality agreement can be an important instrument for effective cooperation between the owner and the CMO. A quality agreement should indicate which party will determine the specifications of the components and which party will define procedures for reviewing, qualifying and tracking component suppliers. It is also necessary to determine who will perform the tests or samples necessary to comply with the PMCs. The new enforcement program has the effect of strengthening the responsibility of the owner companies that ordered CMOs in compliance with the CGMP rules by their CMOs. As a result, CMOs may find that their clients are increasingly concerned about assessing the state of compliance in the CMO, including strengthening quality monitoring of proprietary businesses on CMO activities. The FDA continues to inspect CMOs in the same way as before. It is expected that the owner companies that have mandated the CMO will increasingly be subject to regulatory action due to violations of PMCs in their CMCs. Previously, it was rare for companies that owned the drugs and mandated CMOs to be cited for CGMP errors in their CMOs.
As outlined in the FDA`s draft guidelines, the FDA considers the contractually agreed schedule to be the contract provider`s extension. This view is supported by Regulation CGMP 21 CFR 211.22 (a), which states that « the quality control unit is responsible for the authorisation or refusal of drugs manufactured, processed, packaged or contracted by another company » (2). The agreement should not include such elements as terms and conditions, pricing and stair terms, forecasts, delivery conditions, confidentiality obligations and liability limitations. These items are included in the delivery agreement, which is a separate document. The quality agreement can be included in the reference supply agreement. If both documents are drawn up in one document, the authorization list may contain individuals who have no reason or time to check for problems that have nothing to do with their area of expertise. 7.11 clearly defines and discusses the relationship between the contractor and the contractor, and the second (user) should not at any time outsource to a third party without prior evaluation and approval of the agreements by the donor.