An effective quality agreement reduces these potential risks. Despite the fact that quality agreements are not mandatory under current CGMP requirements, they can often be more effective in improving quality systems and maintaining quality compliance within the supply chain. Effective quality agreements also strengthen communication between organizations, resulting in more frequent interactions with quality assurance groups and giving each organization a better idea of its quality. The contract expires at the end of the delivery contract. The agreement may be amended, if necessary, with the written agreement of both parties. 1.1.1. This agreement defines the roles and responsibilities of BAXTER Quality Operations in providing services to IDEC. Do you have quality agreements with your payroll manufacturers, co-workers, payroll labs and component suppliers? If not, we can help you develop and implement quality agreements with your suppliers throughout your supply chain. For information on how Weinberg Group can help your company meet cGMP compliance in the pharmaceutical supply chain, contact us today.
At the request of the customer, a final draft of BAXTER`s additional documentation is submitted to the customer on a date fixed by mutual agreement between the parties, for verification by the customer. Customer will make available to BAXTER its comments on this project as soon as possible upon receipt, and BAXTER will then provide Customer with final additional documentation containing customer feedback to fda, no later than thirty (30) days after receipt of customer feedback from BAXTER. 8.1.2. BAXTER will ensure the approval of IDEC before introducing an obligation vis-à-vis a regulatory authority regarding the PRODUCT. Draft responses to regulatory comments directly related to the PRODUCT and its manufacture are provided to IDEC before being submitted to the regulatory authorities, and BAXTER allows IDEC to introduce responses and corrective actions. BAXTER retains final power over the content of responses to the regulatory authority. 1.2.1. This agreement is included in and part of the supply agreement between the two companies. It is customary for the trade agreement and the quality agreement to contain provisions relating to the same subject matter, for example. B examination fees or transfer of technology. Preferably, there should be no duplication and one of the documents should simply refer to the provisions of the other agreement instead of repeating or repeating the same provisions. 8.3.6.
Subject to the conclusion of a confidential disclosure agreement between BAXTER, IDEC and IDEC licensees, BAXTER will grant IDEC licensees access to BAXTER`s premises for audit purposes, in accordance with the restrictions set out in 8.3.2 to 8.3.4. IDEC accompanies licensees during each audit, provided that the audit is directly related to the IDEC PRODUCT. If both agreements contain provisions relating to the same subject-matter, these must be carefully examined in the event that one of the agreements is subsequently amended.