Manufacturing and Packaging Changes Clause Samples
The Manufacturing and Packaging Changes clause defines the procedures and requirements for making alterations to the way a product is produced or packaged. Typically, this clause outlines the need for prior notification, approval processes, and documentation when changes are proposed, ensuring that all modifications meet regulatory standards and contractual obligations. Its core function is to maintain product consistency, quality, and compliance, while preventing unauthorized or unapproved changes that could impact safety, efficacy, or marketability.
Manufacturing and Packaging Changes. (a) REQUIRED CHANGES. With respect to changes to the Product Specifications or manufacturing relating to the Products that are required by laws and other Regulatory Requirements (including, without limitation, cGMP), or by medical or scientific concerns as to the toxicity, safety and/or efficacy of the Products (collectively, "REQUIRED CHANGES"), the Parties shall cooperate in making such Required Changes promptly, and Seller shall promptly provide written notice for each such Required Change to Buyer.
Manufacturing and Packaging Changes