Batch Record definition

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

• Standard operating procedures (How to write), Master Batch Record, Batch Manufacturing Record, Quality audit plan and reports.

• Batch Record: A very first page of the BMR has all records about the batch as batch number, batch size, composition, master formula record referred the weight of the batch, shelf life, storage conditions, manufacturing license number, manufacturing date, expiry date, date of starting and date of completion.

• 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.

• In addition, Hospira will provide Theravance with a copy of the Master Batch Record and all other documents and records as required by the Quality Agreement for Theravance’s release of the batch and such samples of the batch that Theravance may reasonably request.

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 all of the documentation associated with the production and testing of a given Batch, including production records, sampling documentation as recorded in the Batch Record, test results, Investigative and Corrective Action Reports, deviation reports, all applicable Manufacturing Process data (including any pertinent output from instrumentation), the Certificate of Compliance and any additional Quality Review and Approval documentation.

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 is defined in the applicable QAG.

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 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;