Quality Agreement Addendum
Work closely with your subcontractor or supplier to ensure that the agreement is satisfactory. Several drafts on round-trip communication are likely. Additional FDA controls: In addition to design controls, you should also describe the labeling, production, process, and packaging controls that your device must follow. Just like with design controls, you need to clarify in your agreement the steps your contract manufacturer must take to comply with the regulations. If you believe your quality agreement is complete, review the appropriate sections of 21 CFR Part 820 with your quality and legal teams to ensure that your agreement meets FDA requirements. Duration of the agreement: In simple terms, the quality agreement must have clear start and end dates and must set out all the conditions that would lead to a termination of the contract. A quality agreement ensures that you and your material supplier or contracted manufacturer are on the same page by laying the foundation for quality and communication standards. It plays a crucial role in avoiding fines, which can amount to tens of millions of dollars for some medical device companies, and in providing the best possible product. 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.
A quality agreement is not just a set of legally binding rules. It is also an integral part of supplier management and facilitates the establishment of an employment relationship. The process of creating a quality agreement makes this relationship clear: a medical device quality agreement is a written agreement that ensures that suppliers manufacture your product and send you materials to predetermined specifications. Quality management protocols: Specify how you want the vendor to handle material storage, a CAPA-related event or non-compliance, or other quality factors. Nomenclature and cost negotiations: It is best to determine material costs, shipping and delivery windows, etc. before you start. Formulate everything in your supplier agreement to ensure that there are no unpleasant surprises when production starts. Once both parties are satisfied with the agreement, ask your legal team to conduct a full review. Your legal team will review the agreement and ensure that all the necessary legal wording is in place and that the agreement meets the organization`s requirements. Liability issues: Contact your legal counsel to clarify any liability issues in advance and explain these safeguards in your agreement with the provider.
Who to contact in terms of quality and corrective and preventive actions (CAPA): You must contact your supplier in the event of a quality event such as non-compliance or capA. The quality agreement will specify who to contact, how to contact them and what additional measures to take. Once your quality agreement is finalized, both parties can begin the real process of collaborating and implementing the agreement. Quality Management Requirements: Define whether the supplier should apply a quality management system (QMS). You must provide details on how to manage the appropriate processes within the QMS and assign responsibility for the tasks to be performed by members of your organization. For example, you need someone to take care of updating a supplier relationship movement within the QMS. Plus, it`s a good idea to invite them to your quality management platform if you`re already using one. Some regulators around the world may need a quality agreement. But others, like the U.S. Food and Drug Administration (FDA), don`t require medical device manufacturers to have a quality agreement. A quality agreement focuses solely on the FDA`s current Good Manufacturing Practices (GMPCs), which describes the following: Remember: Even if the FDA doesn`t require a quality agreement, it shows them that you take quality seriously.
Insisting on a quality agreement from the beginning also signals to your potential partners that you prioritize quality and that your business is likely to be efficient and more likely to make a profit. Procedure protocols: The quality agreement must include all protocols, e.B how to handle materials or what documentation needs to be updated. Terms and Conditions: Use this section to determine working hours and any termination clauses and to determine who should be contacted regarding anything outside of CAPA and the quality issues described in the quality agreement. Workplace: The agreement should dictate where the supplier will perform the work, and multiple locations should be named if there is more than one construction site. Many companies also require notification in case the supplier relocates its operations. Quality agreements also keep you informed of your supplier and reduce the likelihood of something going under your radar. Quality agreements require cooperation between both parties, so it`s only natural that you and your partner communicate better over time while ensuring that the agreement is respected. Design Controls: If you are creating a Class II or III medical device, you must comply with FDA design control requirements and document all related procedures and activities in your quality agreement. This ensures that your product is developed and designed with certain safety measures in mind. All relevant stakeholders meet and start working together on the agreement. It`s not a requirement for lawyers to be present, but their insight is valuable.
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