Customer Quality Agreements

Supplier and supplier quality agreements define the quality conditions of materials or services provided at a production site and used in products or product manufacturing. Service quality agreements define the quality conditions of services provided at a production site and used in the manufacture of products. The text of the quality agreement should be drafted in accordance with the expectations of regulators, as stated in their respective regulatory documents. In addition, a matrix of responsibility should be included in each quality agreement to clarify the responsibilities of each party. Drugs not manufactured in accordance with CGMP are considered to be denatured in accordance with Section 501 (a) (2) (B) of the Federal Food, Drug, and Cosmetic Act (FD-C Act). Under this Act, a drug is distorted « if the methods used in the facilities or controls used for manufacturing, processing, packaging or establishment do not comply with the CGMP. » The manufacture, processing, packaging or maintenance of a drug is defined as « the process of packaging and labelling, testing and quality control of medicines » (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. It is only in the last decade that pharmaceutical quality agreements in the United States have become a practical and enforceable document that lays the foundation for a productive cGMP relationship.

This improvement is largely due to the fda and European regulators` guidance on this issue (see the FDA`s draft guidelines, « Contract Manufacturing Arrangements for Drugs: Quality Agreements » and EU cGMP Chapter 7). It is also worth mentioning what can be excluded from a quality agreement. Among the points that should never be included in a quality agreement are: quality agreements help both parties to carry out the overall review of the contract. They define, define, define, define and document the roles and responsibilities of all parties involved in the process. Quality agreements allow each party to define its expectations and rules for projects and to ensure that the quality characteristics of both parties are coordinated and that each party receives effective quality services and products.