Batch Documentation definition

Batch Documentation has the meaning set forth in Section 6.2.

Batch Documentation means the documentation provided to Myovant or the Qualified Designee (as defined below) at the time of delivery of Drug Substance, as agreed upon by the Parties in the Quality Agreement or as required by Applicable Laws.

Batch Documentation means, for each Batch, the Certificate of Compliance and the Certificate of Analysis.

Examples of Batch Documentation in a sentence

• BatchA homogeneous and defined quantity of starting material, medicinal prod- ucts or packaging material produced in a single operation or in a series of operations Batch DocumentationThe Batch Documentation includes instructions and protocols on manu- facturing and packaging procedures, as well as the test report.

• The Batch Documentation serves as a basis for the batch release and is particularly important when, at a later stage, qual- ity defects are identified which were not detectable at the time of release.Bulk WareB= Any product which has passed through all processing stages except for final packaging.

• Batch DocumentationThe Batch Documentation includes instructions and protocols on manu- facturing and packaging procedures, as well as the test report.

• The Batch Documentation serves as a basis for the batch release and is particularly important when, at a later stage, qual- ity defects are identified which were not detectable at the time of release.ABatch Record Review BBatch Record Review is a system that collates all the information about the batch certification.

• If Alnylam requires additional copies of such Batch Documentation, these will be provided by Manufacturer to Alnylam at cost.

More Definitions of Batch Documentation

Batch Documentation means the Certificate of Compliance, the Certificate of Analysis, the Specifications, and a complete and accurate copy of the executed Batch Records.

Batch Documentation means all completed batch records, batch deviations, raw data, reports, authorizations, certificates, raw material specifications, standard test methods, and other documentation in the possession or under the control of a Party (or its vendors) relating exclusively to the Manufacture of each Batch.

Batch Documentation means the documents and other records that are produced in connection with the Manufacture of a particular Batch and/or lot.

Batch Documentation means, with respect to each non-GMP and GMP Batch delivered hereunder, the batch documentation described in Sections 8.1.1 and 8.1.2, respectively; provided, however, that (i) in no event (and notwithstanding anything to the contrary elsewhere in this Agreement) shall Tekmira be required to provide any Formulation Design Know-How and (ii) subject to the provisions of Sections 11.2 and 11.3 all Batch Documentation, and the provision thereof hereunder shall be subject to the restrictions set forth in the Restated Tekmira LCA and Restated Protiva CLA with respect to the use and sublicensing of Tekmira Technology, Protiva Patent Rights and Licensed Information (as defined in such agreements).

Batch Documentation means a complete copy of the approved executed Batch Record, master Batch Record, release testing results, Certificate of Analysis for Product or Applicator, as applicable, and Certificate of Compliance for Product and Applicator, as applicable.

Batch Documentation means complete and accurate copies of all of the following, as applicable: Albemarle audited production batch records, deviation reports, investigation reports, a COA, Product release chromatographs and corresponding calculations for all batches, management of Change (MOCs), cGMP certificate of compliance, and stability data, when available (including one chromatograph utilizing one condition for each pull interval from one batch). For the sake of clarity, originals of the Batch Documentation will be retained by Albemarle and made available for inspection for all batches produced, including aborted batches, and a complete copy of Batch Documentation shall be furnished to Customer in accordance with Section 3.2.

Batch Documentation means with respect to a Batch, a complete and accurate copy of the Batch records, a Certificate of Analysis (if applicable), and/or a Certificate of Compliance (if applicable), and a complete and accurate copy of any other documents specified in the applicable Scope of Work as being OXB’s responsibility to provide to Client with respect to a Batch;