Part of the agreement should address specific product-specific considerations. It should also define how owners pass on knowledge, such as product information and process development, to contracting entities to ensure that manufacturing is compatible with CGMP. To learn how to optimize the coordination of quality agreements and other order manufacturing functions with digital tools, read the TrendBrief «3 Ways Contract Manufacturing Organizations Are Looking to Digital Technology to Improve Collaboration». The FDA has no specific guidelines regarding quality agreements between medical device companies and the CMOs that provide services to them. However, fda guidelines state that quality agreements should cover activities under 21 CFR Part 820, the Quality System Regulation (QSR) for medical device companies, «where applicable.» Given the inclusion of Part 820 in the Guide, a quality agreement between a medical technology company and a CMO should address the following aspects to varying degrees, depending on the nature of the relationship between the two parties and the products and services involved: the speed of innovation and competition in the life sciences is relentless. This is prompting more and more companies to adopt light asset operating models, which rely heavily on an ecosystem of order manufacturing organizations (CMOs). As a result of this trend, the burden of complying with the current Good Manufacturing Practices Guidelines (GMPCs) is increasingly shared between the companies that own products and the contract establishments on which they depend. A strong quality agreement is the first step for both parties to be responsible and cooperate to comply with the rules imposed by the US Food and Drug Administration (FDA). The order manufacturing contract is the main contract covering all the conditions of sale agreed by the parties.
These terms generally include prices and costs, volume, production plan, supply, confidentiality and non-infringement, non-competition, termination, limitation of liability and damages for infringement. A quality agreement should indicate which party will define component specifications and which part will define processes for auditing, qualifying and monitoring component suppliers. It should also be determined who carries out any tests or sampling necessary to comply with the CGMP. The EU MSG Guide, Chapter 7, on outsourced activities, clearly sets out expectations for quality contracts.. . .