This manufacturing quality agreement template has 5 pages and is a MS Word file type listed under our legal agreements documents.
Sample of our manufacturing quality agreement template:
MANUFACTURING QUALITY AGREEMENT This Manufacturing Quality Agreement (hereinafter "Agreement"), is made and effective [DATE], BETWEEN: [MANUFACTURER/COMPANY NAME] a Limited Liability Company (hereinafter called the "Manufacturer") organized and existing under the laws of the [STATE/PROVINCE] with its head office located at: [COMPLETE ADDRESS] AND: [CUSTOMER/COMPANY NAME] a Limited Liability Company ( hereinafter called the "Customer") organized and existing under the Laws of the [STATE/PROVINCE]; located at: [COMPLETE ADDRESS] WHEREAS the Manufacturer supplies [DESCRIBE PRODUCT] suitable for use to the Customer and; WHEREAS the Manufacturer is involved in the manufacturing, selling and distribution of [DESCRIBE PRODUCT] to the Customer. NOW, THEREFORE, THE PARTIES AGREE AS FOLLOWS: PRODUCTS COVERED BY THE AGREEMENT This agreement pertains to the following product(s)(or product processes/types/locations, etc.), hereafter referred to as Products: [LIST PRODUCTS] QUALITY & CRITERIA 2.1 The Manufacturer will manufacture, test and release the product in accordance with the following quality criteria: [LIST QUALITY CRITERIA] 2.2 This Quality Agreement will outline the responsibilities of the Manufacturer and the Customer with regard to the quality activities described in the quality criteria listed above. SITE(S) INVOLVED The sites manufacturing the Products are mutually agreed upon and located at: [MANUFACTURING SITE LOCATION] USE OF THIRD PARTIES If the Manufacturer uses third parties to manufacture, package, label, test or release the product(s), such use is set forth [LIST HERE OR SPECIFY ATTACHMENT]. Changes in the use of third parties as set forth in this agreement will not be made without prior written notification to the Customer. The Manufacturer shall, however, retain all obligations under this Agreement whether a third-party manufacture, packages, labels, inspects, tests, releases or handles the product(s). TERM OF AGREEMENT 5.1 This Agreement shall become effective and binding upon the date of the final signature and shall remain in effect until [TOTAL YEARS] years after the last delivery of product(s) by the Manufacturer to the Customer unless the Customer specifically requests an extension of the Agreement. Either party may terminate this Agreement by giving 6 (six) months written notice to the other party. After such termination, and if so, requested by the Customer, the Supplier will negotiate with the Customer in good faith a subsequent Quality Agreement. ASSIGNMENT 6.1 Neither party shall have the right to assign any or all of its rights or obligations under this agreement without the other party's prior written consent, which shall not unreasonably be withheld. The foregoing notwithstanding, prior written consent shall not be required in connection with a merger, consolidation, or a sale of all or substantially all of party's assets to a third party, except if such merger, consolidation, or sale is with a competitor of the other party. OTHER AGREEMENTS 7.1 If a Manufacturer and/or Supply Agreement is in place between the Manufacturer and the Customer, and there are any inconsistencies between the Manufacturer and/or Supply Agreement and the Quality Agreement, the Manufacturer and/or Supply Agreement will take precedence over the Quality Agreement. COMPLIANCE The Manufacturer and Customer conform to the quality criteria defined in Section 2 of this agreement. The Manufacturer and Customer mutually agree upon specifications for the products which are the subject of this agreement. Changes to the agreed upon specifications must be mutually agreed upon and communicated in writing between the parties to this agreement, except for compendial changes which can be implemented without mutual agreement. Compendial changes must be implemented by the compendial implementation date. The Manufacturer and Customer ensure that the specifications for compendial products are in compliance with the current compendia. The Manufacturer agrees to manufacture products that conform to the mutually agreed upon specifications. Upon request, the Manufacturer will disclose to the Customer recent regulatory agency inspections and findings pertaining to the products. The Manufacturer and Customer will promptly notify one another if, in the course of a regulatory inspection, negative findings are made related to the quality of the products supplied. The Manufacturer shall have a quality agreement with third parties used for production, packaging, testing or processing the products in any manner, which could be viewed during an audit. MANUFACTURING, PACKAGING AND LABELING The Manufacturer shall document that manufacturing and packaging process are fit for purpose. The Manufacturer shall demonstrate the commissioning of critical systems and equipment used in the manufacture and control of the product. The Manufacturer shall demonstrate that cleaning procedures are appropriate, and their effectiveness has been proven. Product samples will be retained for a period of [TOTAL YEARS] years by the Manufacturer. The Manufacturer and Customer agree upon special labelling requirements. DOCUMENTATION AND RECORDS The Manufacturer agree to provide a Certificate of Analysis with the release of each product batch sent to the Customer
