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

• Lonza shall manufacture and deliver Process Validation Batches as mutually agreed by Parties sufficient to document the operability and reproducibility of the Manufacturing Process and permit the Parties to complete and file the necessary regulatory documents.

• Packaging Design Services See Separate Quote Process Validation $[**] Per executable document Validation of batches billed for each executable document, based on discussions between Sharp and Customer’s QA teams.

• Please be advised that an additional phase, Process Validation, will be required before introducing the products to market.

• The cost of all such regulatory support activities are excluded from the Price of Process Validation Batches, shall be approved by Forty Seven in advance, and shall be paid for by Forty Seven at the Price set out in the applicable Project Plan.

• On not fewer than * calendar days in advance of the desired Product availability date after Process Validation Completion or on such other schedule as agreed upon by the Joint Project Team (the “Initial Order Date”), Client will place its first firm Purchase Order for Product (the “Initial Order”).

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 means establishing by objective evidence that a process consistently produces a result or product meeting its predetermined specifications.

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