The first step is to understand the uniqueness of each document, and then see how, together, they form a dynamic foundation for all aspects of a business relationship. The quality agreement is a comprehensive written agreement (usually supplemented by a checklist) that defines and defines the quality and GMP obligations of each party involved in the contract manufacturing of food supplements. In general, the quality agreement should specify the responsibilities that are assigned to each party in accordance with the applicable requirements under Part 111 of 21 CFR and other current industry standards. It will serve as a basis for dispute resolution, audits and access to product information. The agreement must specify which controlled and documented changes can be made by the contractor, with only notice to the owner and which must be discussed, reviewed and approved by the owner before they can be implemented. Quality agreements are not only good business practices, there are also regulatory requirements for them. ICH Industry Guide Q7 Good Manufacturing Practices Guide for Active Pharmaceutical Ingredients recommends that owners evaluate contract facilities to ensure contractors` sites are GMP compliant for specific operations. Written agreements should also set out subcontracting considerations. They should describe how changes to processes, equipment, methodologies and specifications are managed, and allow the owner to verify compliance with the PMCCs of their contractor`s facilities. Work closely with your subcontractor or supplier to ensure that the agreement is satisfactory. Several drafts on round-trip communication are likely. „Your company has failed to create a quality plan that defines relevant quality practices, resources, and activities for products designed and manufactured in accordance with 21 CFR 820.20(d).

In particular, your company has not entered into a quality agreement with the contract manufacturer of EZ Spacer nebulizers. Responsibilities between FCS and the contractor are not clearly defined. In addition, a similar observation was made regarding your failure to enter into a quality agreement with your contract manufacturer of the drug [.] The ICH Guidelines for the Industry Pharmaceutical Quality System Q10 recommend that, as part of a pharmaceutical grade system, the owner is ultimately responsible for ensuring that „processes are in place to ensure the control of outsourced activities and the quality of materials purchased.” It should be noted that these processes should include quality risk management and include essential activities, such as. B:: A standard working procedure should be in place to indicate the types of suppliers and services for which a quality agreement is required. At the very least, an agreement must be reached every time a CMO is used, as well as with all suppliers of critical materials. They are recommended for suppliers of large quantities of raw materials or components. Quality agreements should be prepared by the quality assurance (QA) functions of both parties with the participation of relevant operating personnel, such as manufacturing and laboratory personnel .B. They must be approved by the quality assurance function of both parties and the operations department of both parties. The legal department may or may not be involved in the quality agreement.

The involvement of the Legal Service in the preparatory phase would ensure that the quality agreement complies with the supply agreement. However, this may delay the execution of the quality agreement if the legal department wishes to add unnecessary legal wording that has no place in the quality agreement. You must also ensure that your agreement specifies exactly what will be delivered with the materials supplied, in what degree of purity, to what extent and the delivery time. In summary, quality assurance agreements are not only the expected control method for high-risk suppliers, but can also provide clearer and smoother processes for both the manufacturer and the supplier. Those who need to know the content of the quality agreement in order to do their job should be involved in reviewing the agreement, including business development, project managers, and law (to ensure compliance with the supply agreement). Quality agreements and agreements with suppliers are essential for the placing on the market and maintenance of a medical device. In this context, the two define different requirements in the relationship between the manufacturer and the supplier. Privacy: Your supplier may be aware of information about your product or process that is not intended for the public, or at least not intended for the public at this time. Use this section of your agreement to make sure both parties know what can and cannot be shared with the public – or competitors. Quality agreements between suppliers and suppliers define the conditions relating to the quality of materials or services delivered to a production facility and used in the products or in the manufacture of the products. Quality of service agreements define the conditions relating to the quality of services provided to a production facility used in the manufacture of products.

One of the most overlooked sections in FDA guidelines is the definition section. It is important for everyone to know what is meant by each term used in the quality agreement; especially for contracts with non-U.S. citizens. Parts, the terminology can be very different. Add abbreviations and acronyms and define documents – one person`s batch record is another person`s data sheet. Define „subcontracting” and if and when it is acceptable. The ultimate goal of your quality agreement: Determine the scope of the project, the expectations of both parties and the ultimate goal of the agreement. This section is essentially the terms of the entire relationship. An agreement with suppliers focuses more on liability and logistics issues, including the following: the scope of the quality agreement should cover several compliance activities, such as. B, the qualification, calibration and maintenance of analytical instruments and manufacturing equipment; Validation of computer systems, analytical methods and manufacturing processes; the specifications used to pass or fail analytical tests; handling, storage and preparation of supplies; receipt, analysis and communication of samples; collection and management of laboratory records; and variance management and change control.

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