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

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

Examples of Batch Records in a sentence

• 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.

• In the event that Customer requires additional copies of the Batch Records, these will be provided by BVL to Customer at mutually agreed upon fees.

• With due regard to information and operations which constitute Proprietary Information of Cardinal Health, duly-authorized employees, agents and representatives of Reliant shall have the right to inspect Cardinal Health Batch Records relating to Product and those portions of Cardinal Health’s Facilities used for Manufacturing and Packaging Product.

• Subject to Section 2.8, as agreed between the Parties pursuant to the Quality Agreement, Emergent shall maintain the Master Batch Records related to the Manufacturing of Products under this Agreement.

• LWI will retain possession of the Master Production Record, all Batch Records and LWI Operating Documents, and will make copies thereof available to CLIENT upon CLIENT’s request and at CLIENT’s expense.

More Definitions of Batch Records

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, with respect to a particular production run conducted by or on behalf of Arena for manufacturing one Batch of a particular 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 shall have the meaning set forth in Section 6.1.

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 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 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 the final executed batch production records for each Batch of Product Manufactured under this Agreement, prepared in accordance with cGMP, if applicable.