The guidelines encourage homeowners to verify and approve most changes before being implemented. But in certain circumstances, there are changes that contractors can implement without notifying the owner. A quality agreement must determine how all these changes are made and managed. Traditionally, the role of the quality agreement has been to allocate responsibility between the client (owner) and the contractual facility (CMO). The CGMP Regulations (21 Code of Federal Regulations [CFR] 210 and 211) required that all pharmaceutical companies (men and animals, pharmaceuticals and biologics) have written procedures establishing the responsibilities/procedures of their quality organizations (2). The FDA`s draft guidance document on quality agreements contains proposals/recommendations regarding the use of quality agreements as effective tools to help meet the regulatory objective. There are four types of quality agreements: manufacturing, supplier, supplier and quality of service agreements, which are tailored to the relevant aspects of the type of relationship. The FDA`s current position on quality agreements is outlined in the “Contract Manufacturing Arrangements for Drugs: Quality Agreements” guidelines published in 2016. The guidelines expressly state that production activities are the most important element of a quality agreement. It focuses on the seven most important areas that should be addressed in a quality agreement and their specific impact on the quality and control of change. High cost pressures, increased competition, tight margins and inadequate quality systems have led, among other things, to a higher frequency of violations (p.B. FDA-483s, alerts and import alerts) among CMOs. Most CMOs have several customers who enter into contracts with them, and it is not uncommon for owners with different expectations in terms of quality to be present.
In addition, quality agreements have often only been discussed after supply contracts have been signed. Quality assurance should prepare the agreement with manufacturing and laboratory staff on both sides. The functions of the SQ of both parties should review and approve the quality agreement. Nothing should be taken for granted. Each party must review the quality agreement to ensure that its requirements are taken into account. Manufacturing quality agreements are comprehensive written agreements between the drug manufacturing parties that define each party`s manufacturing activities and determine how each party respects cmIM.