Batch Disposition Documentation definition

Batch Disposition Documentation means all of the documentation associated with the production and testing of a given clinical Batch, including without limitation production records, sampling documentation, test results, Investigative and Corrective Action Reports, deviation reports, all applicable Manufacturing Process data (including any pertinent output from instrumentation), the Certificate of Analysis, the Certificate of Compliance and any additional Quality Review and Approval documentation, if applicable.
View Source
Batch Disposition Documentation means all of the documentation produced by LONZA and its Subcontractors and associated with the production and testing of a given Clinical Batch, including without limitation production records, sampling documentation, test results, Investigative and Corrective Action Reports, deviation reports, all applicable Manufacturing Process data (including any pertinent output from instrumentation), the Certificate of Analysis, the Certificate of Compliance and any additional Quality Review and Approval documentation, if applicable. Batch Disposition Documentation requirements will be specified in the Quality Agreement (Exhibit C).
View Source

Examples of Batch Disposition Documentation in a sentence

  • LONZA shall provide PROTEON’s quality assurance department with copies of completed Batch Disposition Documentation, and shall endeavor to do so within ten (10) Business Days of Quality Review and Approval.

  • Such request shall be accompanied by Client’s written acknowledgement that the Clinical Batch has been delivered without the transmittal to Client of Batch Disposition Documentation, that accordingly the Clinical Batch cannot be administered to humans until Quality Assurance Release and transmittal of the Batch Disposition Documentation, and that Client nevertheless accepts full risk of loss, title and ownership of the Clinical Batch.

  • LONZA shall complete Quality Assurance Release and shall deliver to Client the necessary Batch Disposition Documentation and Clinical Batch Sample.

Related to Batch Disposition Documentation

  • Acquisition Documentation collectively, the Acquisition Agreement and all schedules, exhibits and annexes thereto and all side letters and agreements affecting the terms thereof or entered into in connection therewith.

  • Related Documentation means, with respect to Software, all materials, documentation (including control documentation utilized in connection with an audit), specifications, technical manuals, user manuals, flow diagrams, file descriptions and other written information that describes the function and use of such Software, but excluding source code.

  • Acquisition Documents means the Acquisition Agreement, all other agreements to be entered into between or among the Acquired Company or its Affiliates and the Borrower or its Affiliates in connection with the Acquisition and all schedules, exhibits and annexes to each of the foregoing and all side letters, instruments and agreements affecting the terms of the foregoing or entered into in connection therewith.

  • Permitted Securitization Documents means all documents and agreements evidencing, relating to or otherwise governing a Permitted Securitization Financing.

  • Program Documentation refers to the user manuals, help windows, readme files for the Services and any Oracle Software. You may access the documentation online at ▇▇▇▇://▇▇▇▇▇▇.▇▇▇/contracts or such other address specified by Oracle.