Supplier Quality Agreements Fda

While it is in the interest of suppliers to maintain a high level of quality to attract customers, the regulatory burden ultimately falls on the company receiving its products or services. In addition to defining the content of a vendor agreement and reviewing concrete examples, this presentation helps you decide how best to implement these agreements in your business. Supplier control has always been a requirement of the FDA and ISO 13485, but the current expectation is that you effectively document this control as part of your vendor management program, and the SAQ agreements can be an easy way to demonstrate this control to major or critical suppliers. This presentation will help you understand what the current guides that you include in the supplier agreements offer. Quality assurance (QS) contracts are generally more flexible than standard supplier agreements and can therefore be more detailed and simpler to modify than standard supplier contracts, which often require legal and management authorization. SAQ agreements with your suppliers can be the easiest way to assure your business and external auditors that you have sufficient control over your key critical suppliers. The SAQ agreements indicate who is responsible for what between you and your supplier. However, since these agreements are detailed and specific to a particular supplier, they should only be used for suppliers when they provide value. Even if your major suppliers come from only different branches of your own business, a supplier quality agreement can be an important tool to show fda reviewers and ISO 13485 that you have the necessary control over these suppliers. The quality agreement must be developed and mutually accepted by the CMO and the customer prior to the acceptance of the supply contract, in order to ensure the identification of all invoiced items and any capacity restrictions. Take our free white paper with practical advice for qualified suppliers and quality management. Quality agreements should be developed by the quality assurance functions of both parties, with the participation of the operational staff involved, for example.

B manufacturing and laboratory staff. They should be approved by the SQ function of both parties and by the operating department of both parties. The legal division may or may not participate in the quality agreement. The inclusion of the legal division in the preparatory phase would help to ensure that the quality agreement is in line with the delivery agreement; It may, however, delay the performance of the quality contract if the legal department wishes to add unnecessary legal formulations that do not fall within the quality agreement.