Process validation definition
Process validation means documented evidence providing a high degree of assurance that a specific process will consistently produce a product meeting its predetermined specifications and quality attributes.
Process validation means demonstrating that when a process is repeated within specified limits, the process will consistently produce preparations complying with predetermined requirements. If any aspect of the process is changed, the process would need to be revalidated.
Process validation means the successful completion of the testing and development process related to the leukocyte reagent component of Seller's Urine Chemistry Products, as identified in Exhibit H hereto.
Examples of Process validation in a sentence
Process validation batches will not be included in determining the Yield Rate.
As used herein, “Subpar Yield” means a yield in comparability runs in the Singapore Facility that is more than [***] lower than the average yield obtained in new Process validation runs conducted in the Walkersville Facility.
Catalent shall Process validation Batches and perform validation services at prices to be agreed in writing between the parties.
Process validation and transfer of the COLLABORATOR Process into Module is entirely the responsibility of COLLABORATOR.
Process validation results are required to substantiate that manufacturing procedures are in place to minimize biological risks.
More Definitions of Process validation
Process validation means the collection and evaluation of data from the process design stage throughout production, which establishes scientific evidence that a process is capable of consistently delivering quality products.
Process validation means establishing documented evidence that provides a high degree of assurance that a specific process will consistently produce results meeting predetermined specifications and quality attributes;
Process validation. All processes used in the manufacture and packaging of the Product
Process validation means the fully documented and agreed to activities to be undertaken to ensure that a manufacturing process, packaging process, testing methods or
Process validation means validation of the final manufacturing processes to be used for the initial shipment of each Product hereunder in accordance with the terms of the Collaboration Agreement.
Process validation means establishment of documented evidence which provides a high degree of assurance that a specific process conducted by Oculex and/or any Third-Party Supplier, will consistently produce a particular Oculex Product meeting the Specification for such Oculex Product and quality [*] Confidential treatment requested with respect to certain portions of this exhibit attributes for that Oculex Product, in accordance with the FDA document entitled "General Principles of Process Validation", and other FDA documents and regulations, and any applicable similar regulations of any relevant foreign governments.
Process validation means establishing by objective evidence that a process consistently produces a result or product meeting its predetermined specifications. See 21 C.F.R.