Validation Protocol definition

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.
View Source
Validation Protocol means a document describing the activities to be performed in a validation exercise;
View Source
Validation Protocol means a written plan stating how validation will be conducted,
View Source

Examples of Validation Protocol in a sentence

  • The Carbon Emission Scope is the scope of the activity(ies), product(s) or entity(ies) of the licensee for which the Carbon footprint was quantified and calculated by CO2logic and for which the Carbon Neutral Program and Offsetting Services for incompressible GHG emissions were sought, in accordance with the Carbon Neutrality Validation Protocol and the General Terms and Conditions of CO2logic.

  • As provided in Appendix A, Supplier shall manufacture ORPHAN’S three (3) consecutive Production Batches of the Drug in accordance with the pre-approved Validation Protocol for validation purposes.

  • Supplier shall manufacture the Drug in accordance with the Specifications, the Validation Protocol and applicable cGMPs and shall package, label and/or otherwise prepare the Drug for bulk delivery to a Jazz Pharmaceuticals designated drug product manufacturer.

  • If any of the Validation Batches do not meet the Specifications and the acceptance criteria set forth in the Validation Protocol, Supplier shall, at its own expense, for a reasonable period of time not to exceed ninety (90) days, make necessary modifications to its facilities, equipment, processes and/or procedures and, after such modifications, shall manufacture one or more additional Validation Batches which will meet the Specifications and the acceptance criteria set forth in the Validation Protocol.

  • If the larger scale Validation Batches may be sold commercially by ORPHAN and, if such Validation Batches meet the Specifications and the acceptance criteria set forth in the Validation Protocol at the time of FDA approval of a product containing the Drug, the Drug shall be sold, pursuant to the terms of this Agreement, by Supplier to ORPHAN in fulfillment of ORPHAN’S orders for the Drug.


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.
View Source
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;
View Source
Validation Protocol means the validation of lots of API under a validation protocol prepared in accordance with the Quality Agreement.
View Source
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.
View Source
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.
View Source
Validation Protocol a written plan describing the process to be validated.
View Source
Validation Protocol means a written plan stating how validation will be conducted and defining acceptance criteria. For example, the protocol for a manufacturing process identifies processing equipment, critical process parameters/operating ranges, product characteristics, sampling, test data to be collected, number of validation runs, and acceptable test results.
View Source