Process Performance Qualification definition

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 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.

Process Performance Qualification means the program by which it is established that the process equipment, ancillary systems, and the Process are effective and reproducible.

Examples of Process Performance Qualification in a sentence

• 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.

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

• 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.

• Once the Process Performance Qualification is completed, the Parties will discuss in good faith and agree on a minimum yield to be achieved by Supplier using the Customer Provided Bulk Product supplied by Customer to Supplier.

• If the data following completion of the Process Performance Qualification supports a minimum yield that is lower than [***], the Parties agree to work together in good faith to determine the root cause of the problem.

• Any engineering Batches, Process Performance Qualification (“PPQ”) Batches or miscellaneous services required to enable the future manufacture of a Batch of API/Product suitable for commercial sale shall be the subject of separately negotiated “Work Orders” issued hereunder.

• 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.

• 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).

• 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”).

• The ▇▇▇▇ of Materials for this Agreement shall be based on this, but shall be updated on completion of the Engineering Batch and again on completion of the Process Performance Qualification batches and thereafter as may be mutually agreed by the Parties.

More Definitions of Process Performance Qualification

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.

Process Performance Qualification. Means the manufacture of the validation batches identified in the applicable Project Addendum that are intended to qualify the Manufacturing process for commercial manufacture and to support applicable regulatory submissions and approvals.

Process Performance Qualification or “PPQ” means the [***]