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 estab- lishing by objective evidence that a process consistently produces a result or product meeting its predetermined specifications.
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.

Examples of Process validation in a sentence

  • Process validation data on the product have been presented for three batches in accordance with the relevant European guidelines.

  • Process validation for full-scale batches will be performed post authorisation.

  • Process validation for full scaled batches will be performed post authorisation.

  • Process validation data on the product has been presented for three full-scale batches.

  • Process validation data on the product have been presented for three full scaled batches in accordance with the relevant European guidelines.


More Definitions of Process validation

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.
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 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 meansestablishing by objective evidence that a process consistently produces a result or product meeting its predeterminedspecifications.
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. All processes used in the manufacture and packaging of the Product
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.