Batch Records definition

Batch Records means Batch-specific manufacturing, packaging and test records and documentation relating to Processing, packaging and release of each Batch, exception documentation, deviations/discrepancies and additional documentation generated and/or processed as part of the production record of the related Batch.

Batch Records means, with respect to a particular production run conducted by or on behalf of Arena for manufacturing one Batch of a particular Finished Product, the completed batch records, in the form of the Master Batch Records, for such production run containing all the relevant manufacturing details and information for the run, including any deviations.

Batch Records means the executed manufacturing instructions, the executed packaging order, the analytical testing results and any other manufacturing related document, such as deviation or investigation reports.

Examples of Batch Records in a sentence

• Batch files of Legislative Library catalogue records listed in the Checklist may be downloaded from the LLBC Batch Records Download Site or the British Columbia Electronic Library Network.

• The Manufacturing Permitee must establish Standard Operating Procedures and Batch Records that comply with current Good Manufacturing Practices and the MAUCRSA for all products, as outlined by the State Department of Public Health and the Food and Drug Administration.

• In the key step of 4.9.2 (some Navinta Batch Records identify this same step as 4.6.13), ropivacaine base is added to a hydrochloric acid solution and stirred until a clear solution forms.

• Source: Personal communication with Hank Elder cross referenced to QA Batch Records.

• Upon request, Contractor shall provide CO and COR with the following contract funded documents as specified below but not limited to: Process Development Reports; Assay Qualification Plan/Report, Assay Validation Plan/Report, Assay Technology Transfer Report, Batch Records, Contractor/Subcontractor Standard Operating Procedures (SOP’s), Master Production Records, Certificate of Analysis, Clinical Studies Data or Reports.

More Definitions of Batch Records

Batch Records shall have the meaning ascribed thereto in Section 3.9.2.

Batch Records means an analytical report (Certificate of Analysis) that Cardinal agrees to warrant as accurate to a reasonable degree of scientific certainty, a quality assurance yield analysis, quality assurance assay release report, and a copy of all production mix change/deviations and/or quarantine reports, if used, all prepared in conformance with the cGMPs.

Batch Records means, with respect to a Batch, the documents, prepared in accordance with cGMP, recording the relevant Manufacturing or packaging of the API Bulk Drug Substance, including the controls, quality specifications, regulatory and other requirements, under which such Batch of API Bulk Drug Substance was Manufactured or packaged.

Batch Records means, with respect to each Presentation of Product to be produced hereunder, a formal set of instructions for the production of each Presentation of Product. Batch Records shall be developed and maintained by the Supplier in the course of Manufacturing separate lots of the Products.

Batch Records means all of the documentation associated with the production and testing of a given Batch, including without limitation production records (including-the master production record). Raw Materials certificates of release, sampling documentation, out of specification and deviation reports, test results, investigative and corrective action reports. all applicable manufacturing process data (including any pertinent output from instrumentation), facility cGMP compliance verifications for the duration of the Batch’s production (including without limitation for Water For Injections (WFI) production system, Heating and Ventilation Air Conditioning (“HVAC”) system and clean room classification attainment at the time that the Batches are produced), the Certificate of Analysis, the Certificate of Compliance and any additional quality review and approval documentation, If applicable. To the extent such documentation has been disclosed by CUSTOMER to NOVASEP, or includes CUSTOMER Background Data, CUSTOMER Pre-Existing IPR, or constitutes CUSTOMER Foreground IPR, or has been developed specifically in relation to a Product, It shall be deemed to be CUSTOMER’s Confidential Information disclosed to NOVASEP pursuant to this Agreement. Otherwise such documentation (other than where It relates to Jointly Owned Foreground IPR) shall be deemed to be the Confidential information of the Party developing or generating the same. To the extent that such documentation relates to Jointly Owned Foreground IPR, it shall be deemed to be the Confidential Information of both Parties jointly In respect of which each Party shall be considered a Receiving Party and shall act in accordance with the confidentiality obligations on a Receiving Party as set out in this Agreement;

Batch Records means, with respect to a particular production run conducted by Biocon for the Manufacture of a single Batch of Clinical Material, the completed batch records, in the form of the Master Batch Records, documenting the details of, and other information associated with, such production run, including any deviations, in accordance with GMP.

Batch Records shall have the meaning set forth in Section 6.1.