Batch Record definition
Batch Record means the production record pertaining to a Batch.
Batch Record means the manufacturing record for a Batch generated by or on behalf of Provider or its Affiliates concurrently with the production of a specific Batch such that successive steps in such processes are documented. The Batch Record is an accurate reproduction of the appropriate Master Batch Record and documents each significant step in the manufacturing process.
Batch Record means a document that records the details required by cGMP and the Quality Agreement about the Manufacture of a batch of a Product, in the form prescribed by the Quality Agreement.
Examples of Batch Record in a sentence
Unless otherwise agreed to by the parties during their ordinary course of dealings, after Catalent completes Processing of a Batch, Catalent shall provide Client with a copy of the Batch Record for such Batch prepared in accordance with the Specifications within [***] of manufacturing; provided that, if testing reveals an out-of-Specification result, Catalent shall provide such Batch Record promptly following resolution of the out-of-Specification result.
More Definitions of Batch Record
Batch Record means, with respect to a Product, the batch production and control record containing the set of detailed processing instructions which are to be followed by Emergent to produce one Batch of the relevant Product as defined in 21 CFR part 211.188, or its successor as in effect from time to time.
Batch Record means a batch manufacturing record, prepared according to applicable cGMP guidelines, for every production batch of API.
Batch Record means the written procedures for production, process control and testing of the Products designed to assure that the Products has the identity, strength, quality, and purity they purport or are represented to possess and is used to ensure uniformity from batch to batch and compliance with cGMPs.
Batch Record is defined in the applicable QAG.
Batch Record and “Master Batch Record” have the meanings assigned to such terms in the Quality Agreement.
Batch Record means the production record pertaining to a specific Batch of Product [***] that is specified in the applicable Work Order, the applicable Quality Agreement or otherwise mutually agreed to in writing by the quality representatives of the Parties.
Batch Record means Manufacturing documentation, packaging documentation, and exception documentation, such as a non-conformance report, Deviation Report and Certificate of Analysis, and additional documentation, which may have been processed as part of the production and packaging records of the Batch;