Medical Device Contract Manufacturing Quality Agreement

This document defines the role and responsibility of each party to maintain the standards for the production and supply of quality health products and related activities. 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) 5 Note: The supplier`s name and the customer`s name may be supplemented by other descriptor information about the company, such as Company X.B, a contract manufacturer of medical devices that properly organizes and is governed by the laws of the jurisdiction. 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. Conversely, a delivery contract explains how the supplier promises to provide all goods or services reported over a period of time and at what cost. It also includes the buyer`s obligations as to when and how the goods are purchased. The delivery agreement helps to facilitate the management of companies working together, eliminates ambiguities and establishes the framework for ordering and delivering goods and services. The EC`s latest guidelines, Chapter 7, have been revised to take into account the ICH Q10 pharmaceutical quality system. He adds that “any activity that falls under the GMP guide and is outsourced should be defined, agreed upon and controlled accordingly to avoid any misunderstanding that could lead to an unsatisfactory quality product or operation. There must be a written contract between the supplier and the evaluator that clearly defines each party`s obligations. If a separate contract laboratory is involved, all relevant roles and responsibilities should be defined.