Process Performance Qualification definition

Process Performance Qualification means the collection and evaluation of data, from the Process design stage through repeated production at final scale, which establishes scientific evidence that a manufacturing process is capable of consistently and reproducibly delivering a Product meeting Specifications, as described in the FDA’s Guidance for Industry, Process Validation: General Principles and Practices, January 2011 (Rev. 1), as amended or updated from time to time.
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Process Performance Qualification or “PPQ” means the process agreed by the Parties for the collection and evaluation of data, from the process design stage through repeated production at final scale, which establishes scientific evidence that a Manufacturing Process is capable of consistently and reproducibly delivering Product meeting Specifications.
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Process Performance Qualification means the program by which it is established that the process equipment, ancillary systems, and the Process are effective and reproducible.
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Examples of Process Performance Qualification in a sentence

  • Such Process Performance Qualification may include, but is not limited to, the following tasks which are more fully described in the Scope of Work: [*].

  • Semnur will approve Product specific qualification/validation protocols as agreed upon and documented in the CCD list per Section 6.2. Process Performance Qualification is not required for Clinical Phase 3 CTM production.

  • Catalent will perform the Product qualification, validation and stability services as described in and in accordance with Process Performance Qualification Protocol No. KP2016-144, as separately agreed by the parties.

  • Following establishment of the Process for a Product pursuant to the Process Performance Qualification, Customer shall be required to purchase at least the minimum number of Batches of Product per quarter, (the “Minimum Purchase Commitment”) as specified in Appendix C.

  • As set forth in the Scope of Work attached hereto as Exhibit B, Sarepta and Catalent have agreed upon pricing for the Technology Transfer Activities, the Development Activities, cGMP Manufacturing Runs and Process Performance Qualification activities to be performed by Catalent under this Agreement.

  • During the Term, Customer may request that Brammer provide certain services related to the Product that are outside the scope of ▇▇▇▇▇▇▇’▇ Manufacture and supply obligations under this Agreement, such as the conduct of Process Performance Qualification or services related to Process development in connection with the Product and the like (“Development Services”).

  • It is understood that Coul▇▇▇ ▇▇▇ order [...***...] of such Batches to be in an amount smaller than the Maximum Batch Size provided that Nordion may produce such a Batch size consistent with regulatory requirements and subject to Process Performance Qualification for such smaller batch size, the cost of which shall be borne by Coul▇▇▇.

  • During the Term, Customer may request that Brammer provide certain services related to Products that are outside the scope of ▇▇▇▇▇▇▇'▇ manufacture and supply obligations under this Agreement, such as the conduct of Process Performance Qualification or services related to Process development in connection with a Product and the like (“Development Services”).

  • For clarity, other than the performance of manufacturing activities to supply the Product(s) ordered by Customer hereunder following a successful Process Performance Qualification campaign, all other activities or services of Brammer shall be considered “Development Services” for purposes of this Agreement and this Section 2.1(ii).

  • For clarity, if Customer has not yet paid the Price for the Lot of Product in question, then Customer’s payment obligations with respect to such Lot of Product shall be stayed until the Third Party expert or laboratory determines that such Lot of Product contains a Defect, and, in the case following establishment of the Process for a Product pursuant to the Process Performance Qualification in accordance with this Agreement and as agreed to by the Parties, that such Defect was caused by a Brammer Failure.


More Definitions of Process Performance Qualification

Process Performance Qualification or “PPQ”). In the event of any conflict between the Scope of Work and this Agreement, the terms of this Agreement shall prevail, except to the extent the Scope of Work expressly deviates from one or more terms of this Agreement and the Parties agree in writing to such deviation.
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Process Performance Qualification or “PPQ” means the [***]
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Related to Process Performance Qualification

  • Monthly Qualification Cycle means a period beginning one (1) Business Day prior to the first day of the current Statement Cycle through one (1) Business Day prior to the close of the current Statement Cycle.

  • pre-qualification means a screening process designed to ensure that invitations to bid are confined to capable providers;

  • Minimum Qualifications means the requirements of education, training, experience and other basic qualifications for a job.

  • Energy Performance Score means the numeric rating generated by Portfolio Manager that compares the Energy usage of the building to that of similar buildings.

  • the qualifying period means the period of 12 years immediately preceding the date of publication of the advertisements referred to in paragraph (A)(iv) above or of the first of the two advertisements to be published if they are published on different dates; and