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. 5 Note: The supplier`s name and the customer`s name may be supplemented by other descriptor information about the company, such as.B. Company X, a contract manufacturer of medical devices that properly organizes and which, in accordance with the laws of the list. Definitions, abbreviations and acronyms The following terms are included in this agreement. Precision An indication of how close a measured value is to the actual (true) value. See also the accuracy. Claim A written, electronic or oral notification of deficiencies in the identity, quality, durability, reliability, safety, efficiency or performance of a device after release for distribution. Model for the quality agreement of medical devices Page 4 of 17. Created by Ombu Enterprises, LLC.
Concession authorization for the use or release of material that does not meet the specified requirements. 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. Dan O`Leary is President of Ombu Enterprises, LLC, a company that provides training and presentations in operational excellence and focuses on analytical skills and an operational management system approach. Dan has more than 30 years of experience in quality, operations and program management in regulated sectors such as aeronautics, defense, medical devices and clinical laboratories. He has a master`s degree in mathematics; asQ Certified Biomedical Auditor, Quality Auditor, Quality Engineer, Reliability Engineer and Six Sigma Black Belt; and has an APICS certification in resource management.