Batch Record definition

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, 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.

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.

• MedCo incorporated the new process into a revised Mas- ter Batch Record, and Ben Venue has made all batches since October 2006 using the new process.

• Batch Record Review is a system that collates all the information about the batch certification.

• Batch Record- Documents prepared for each processed batch which include all ingredients, process details and equipment used to make the product.

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 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 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 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 a complete 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 Drug Substance, Drug Substance testing and lot release data, such that successive steps in such processes may be traced.