Validation Protocol definition

Validation Protocol means a document describing the activities to be performed in a validation exercise;
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Validation Protocol means the written protocol which will be mutually approved by the parties in writing prior to the manufacture of the first Validation Batch and which will set forth the tests and acceptance criteria to demonstrate that a process used by Supplier in the manufacture of the Drug does what it purports to do and yields quantities of the Drug which consistently meet the Specifications. The Validation Protocol may be amended from time to time during the term of this Agreement upon mutual agreement of the parties hereto, giving due consideration to applicable legal and regulatory requirements pertaining to the Drug.
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Validation Protocol means a written plan stating how validation will be conducted,
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Examples of Validation Protocol in a sentence

  • Development of Validation Protocol for analytical and assay methods to defining product manufacturing control, performance, potency and product stability indication.

  • Within two (2) years of Executive Board interim approval of the Emergency Use Method, the entire Single Lab Validation Protocol should be submitted.

  • Technical Methods of Data Collection and Analysis The CMS Performance Measure Validation Protocol identifies key types of data that should be reviewed as part of the validation process.

  • The Laboratory Methods Review Committee will report to the Executive Board on the status of the Single Lab Validation Protocol data submission.

  • HSAG prepared a documentation request, which included the Information Systems Capabilities Assessment Tool (ISCAT), Appendix V of the CMS Performance Measure Validation Protocol.

  • A documentation request, which consisted of the ISCAT or Appendix Z of the CMS Performance Measure Validation Protocol.

  • Measure-specific worksheets based on Attachment I of the CMS Performance Measure Validation Protocol.

  • Validation Protocol Table 3: Resolution of Corrective Action and Clarification RequestsDraft report clarifications and corrective action requestsRef.

  • The Laboratory Committee will report to the Executive Board on the status of the Single Lab Validation Protocol data submission.

  • Qubits and quantical encryption devices could also be convenient ways to provide with qubals.In a situation where we really have a qubal, we have two accessible worlds, A+ and A−,each one having a non-zero probability, according to Born’s rule.


More Definitions of Validation Protocol

Validation Protocol means the protocol which has been or will be mutually agreed upon by the Parties hereto, which describes the tests and acceptance criteria used to demonstrate that a process yields a given Product which consistently meets the Specifications. A *** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission. Validation Protocol may be amended from time to time upon mutual agreement by the parties hereto with respect to a Product, giving due consideration to Legal Requirements.
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Validation Protocol a written plan describing the process to be validated.
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Validation Protocol means a document [***] Confidential treatment has been requested for portions of this exhibit. These portions have been omitted from this exhibit and have been filed separately with the Securities and Exchange Commission. developed by Mikart and approved by Transcept which shall: (i) describe the manufacturing process, (ii) describe objective and measurable criteria for control of the manufacturing process, (iii) define the length and duration of the validation, and (iv) describe the equipment used in the manufacturing process.
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Validation Protocol means the protocol for the production of the Validation Campaign of API, set forth in Exhibit 1.20 attached to and included in this Agreement, as may be amended from time to time by written agreement of the Parties.
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Validation Protocol means the validation of lots of API under a validation protocol prepared in accordance with the Quality Agreement.
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Validation Protocol means the protocols developed by PONIARD and Heraeus setting out predetermined specifications and quality attributes to be met and the procedures to be adopted for any validation activities hereunder;
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Related to Validation Protocol

  • Protocol means, in respect of any category of object and associated rights to which this Convention applies, the Protocol in respect of that category of object and associated rights;

  • Step therapy protocol means a protocol or program that establishes the specific

  • Drug use test means a scientifically substantiated method to test for the presence of illegal or performance-enhancing drugs or the metabolites thereof in a person’s urine.

  • Manufacturing Process means any process for—

  • Technical Specifications A specification in a document defining the characteristics of a product or a service, such as the quality levels, the environmental and climate performance levels, the design for all needs, including accessibility for people with disabilities, and the evaluation of conformity, of product performance, of the use of the product, safety or dimensions, as well as requirements applicable to the product as regards the name by which it is sold, terminology, symbols, testing and test methods, packaging, marking or labelling, instructions for use, the production processes and methods at every stage in the life cycle of the supply or service, as well as the evaluation and conformity procedures;

  • Interoperability means the ability of a CenturyLink OSS Function to process seamlessly (i.e., without any manual intervention) business transactions with CLEC's OSS application, and vice versa, by means of secure exchange of transaction data models that use data fields and usage rules that can be received and processed by the other Party to achieve the intended OSS Function and related response. (See also Electronic Bonding.)

  • Product Specifications means the specifications, features and/or terms of any "Contract" (as defined in the LME Rules) listed for trading on the LME, as described in the LME Rules;

  • Project Implementation Manual or “PIM” means the manual setting out the measures required for the implementation of the Project, as the same may be amended from time to time, subject to prior approval of the Association;