Batch Record Sample Clauses
A Batch Record clause defines the requirements and procedures for documenting the production and processing of a specific batch of products. It typically outlines the information that must be recorded, such as materials used, processing steps, equipment involved, and quality control results, ensuring traceability and compliance with regulatory standards. By mandating thorough and accurate record-keeping, this clause helps ensure product consistency, facilitates investigations in case of deviations, and supports regulatory audits.
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Batch Record. The batch record consists of master manufacturing formula, appropriate packaging ▇▇▇▇ and instructions, and exception documentation, such as NCMRs, deviations, variance reports, and additional documentation which may have been processed as part of the production record of the batch.
Batch Record. Batch record consists of a manufacturing document, packaging document, and exception documentation, such as non-conformance material report, (“Deviation”), certificate of analysis, and additional documentation, which may have been processed as part of the production/packaging record of the batch.
Batch Record. 11.1 Generates the Master Batch Record. [**] [**]
11.2 Approves the Master Batch Record. [**] [**]
11.3 Reviews and approves the executed batch record for each batch of Product. Sends executed batch record to Durata. [**] [**]
11.4 Reviews and approves the executed Batch Record for each batch of product within [**] business days of receipt. [**] [**]
Batch Record. The original source documentation completed during the production of a batch or lot of CLIENT product that gives specific instructions on the procedures, calculations, criteria, sampling, storage conditions and testing performed on that quantity of product. The batch record includes the date, equipment and raw materials used during the process, each operator signature, initials and date and, when applicable, the verifier initials and date at critical steps in the process, the accountability of the material produced and any deviations from the approved procedure. The original, approved batch record that serves as the template to be completed for each production run is referred to as the “Master Batch Record.” CAPA: A corrective/preventative action plan that is initiated to correct or prevent a product or compliance failure and is considered essential to support GMP operations.
Batch Record. The following table gives the details of Batch records: 0 Record Type Required BATCH l Batch Number Default Always empty (no spaces) 2 Biennium Optional 4 bytes, Number, Valid Year date Set to empty (no spaces)
Batch Record. Batch Records will be maintained by the appropriate organizational unit within ▇▇▇▇▇▇ LABORATORIES. Batch Records are available on site for inspection and review by [TP NAME] and/or its agents.