Batch Manufacturing Record Clause Samples
A Batch Manufacturing Record clause outlines the requirements for documenting the production process of each batch of a product. It typically mandates that detailed records be kept for every manufacturing run, including information such as raw materials used, processing steps, equipment involved, and quality control results. This clause ensures traceability and accountability in manufacturing, helping to verify product consistency and compliance with regulatory standards.
Batch Manufacturing Record. 6.1.1 For each batch of Product, INyX will provide Stiefel with a Product Batch Record File, which ▇▇▇▇▇▇es a detailed history and record of the Production run.
6.1.2 The Product Batch Record File provided to Stiefel shall be complete such that all docum▇▇▇▇▇▇▇n required to perform a thorough review of a Production run are present.
6.1.3 Stiefel and INyX shall jointly and specifically develop the details of the Batch File and how it is to be conveyed to Stiefel for final review prior to release of the Product. Refer to Schedule D for a list of documents to be included in the Product Batch Record File.
Batch Manufacturing Record. Device History Record ------------------------------------------------
6.1 ORGANOGENESIS shall complete a batch manufacturing record/device history record for each lot of Product manufactured, retain it in accordance with paragraph 3.4, and upon request shall provide a copy of the record to NOVARTIS.
6.2 ORGANOGENESIS shall document, on the batch manufacturing record/device history record, any investigation of deviations and any action taken to assure that the Product meets applicable specifications.