Batch Record means the production record pertaining to a Batch.
Batch Record means a manufacturing record for a Batch generated by Laureate and approved by Customer made concurrently with the performance of each step of the production, purification and aseptic filling process for the Bulk Intermediate such that successive steps in such processes may be traced.
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.
Examples of Batch Record in a sentence
Each copy of the Master Batch Record for such Batch of Client Product shall be assigned a unique Batch number.
Each Batch of Client Product shall be Produced by using a copy of the Master Batch Record.
Confidential Information of Manufacturer includes, but is not limited to, Manufacturer Technology, including any Manufacturer Technology embodied in any Batch Record or Batch Documentation.
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.
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.
More Definitions of Batch Record
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.
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 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.
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 means a batch manufacturing record, prepared according to applicable cGMP guidelines, for every production batch of API.