Supplier Quality Agreement Definition
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) Quality agreements assist both parties in conducting 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. A reasonably detailed quality agreement can help avoid assumptions that lead to compliance errors. However, while a quality agreement defines the specific quality parameters of a project and the parties responsible for their implementation, the degree of detail varies depending on the stage of development of the project. A quality agreement should at least define the obligations and responsibilities of each party in the following basic elements, as defined in the guidelines: quality agreements for product manufacture are comprehensive written agreements between the parties involved in the manufacture of drugs that define each party`s manufacturing activities and determine how each party will comply with CMIM. If you use QMS to extend compliance responsibilities to suppliers, your agreement should clearly clarify the expectations of their participation. To achieve these benefits while reducing risk, many companies are turning to supplier quality agreements to ensure compliance with internal and regulatory standards.
A quality agreement should include at least the following sections: The FDA does not have a specific policy regarding quality agreements between medical device companies and CMOs that provide them with services. However, FDA guidelines state that quality agreements should cover activities under Category 21 CFR Part 820, the Quality Assurance Regulation (QSR) for medical device companies, «if applicable.» Given the inclusion of Part 820 in the guidelines, a quality agreement between a medical device company and an CMO, depending on the nature of the relationship between the two parties and the products and services involved, should, to varying degrees, address the following aspects: in the eyes of the FDA, any undocumented activity cannot have taken place either. A quality agreement gives the contracting establishment and the owner the opportunity to define the expectations of those who verify and approve quality documents. Protocols should be described for changes to standard operating procedures (SOPS), manufacturing documents, specifications, validation documentation, and all other essential documents relating to products or services provided by the contracting body. The role of both parties in the development and maintenance of original documents or authentic copies compliant with the CGMP must be indicated. The agreement should also clarify how these recordings are easily made available for consultation. It is advantageous to include a statement indicating that electronic records are stored in accordance with CGMP and kept in a searchable condition during the required registration periods, in accordance with FDA requirements. Storage and shipping requirements are an important part of any supplier quality agreement. This may include: What kind of process validation do you need? Do you need information about the process or just a certificate of analysis for the final product they provide? It is important that you specify what should be in the certificate of analysis in order to demonstrate the identity, quality and purity of the product.