Batch Record means the production record pertaining to a Batch.
Batch Record means the document created as and after each Batch is Processed and Packaged. Each Batch Record shall reflect and incorporate all aspects of the Master Batch Record, the applicable Certificate of Analysis, and any Manufacturing Variance Reports issued with respect to such Batch.
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
Each Batch of Client Product shall be Produced by using a copy of the Master Batch Record.
Each copy of the Master Batch Record for such Batch of Client Product shall be assigned a unique Batch number.
Confidential Information of Manufacturer includes, but is not limited to, Manufacturer Technology, including any Manufacturer Technology embodied in any Batch Record or Batch Documentation.
Xxxxxx shall also indicate on the final page of the Released Executed Batch Record that all batch Production and control records have been reviewed and approved by the appropriate quality control unit.
Any deviation from the manufacturing process specified in the Master Batch Record must be documented in the copy of the Master Batch Record for that Batch.
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 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;
Batch Record means the executed Master Manufacturing Record, specifications, in process and release test results, exception documentation, such as deviations and investigation reports, and additional documentation which may have been generated as part of the manufacturing record of each Batch.
Batch Record is defined in the applicable QAG.
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 and “Master Batch Record” have the meanings assigned to such terms in the Quality Agreement.
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.