Audit Check List for Process Validation
1. Is validation, properly done to all critical production procedures? (Indicate all critical production procedures for which validation is done?
a. conducted in accordance with previously defined procedures?
b. result maintained?
c. extension and degree dependable on the value and complexity of the ...
Process Validation Audit Check List
1. Is validation, properly done to all critical production procedures? (Indicate all critical production procedures for which validation is done?
a. conducted in accordance with previously defined procedures?
b. result maintained?
c. extension and degree dependable on the value and complexity of the ...
Traditional process validation
Process validation data should be generated for all products to demonstrate the adequacy of the manufacturing process at each site of production. It is recognized that, at the time of submission, process validation data may not always be available. It is nevertheless essential that valid manufacturing ...
Process Re-Validation
Re-validation is usually done to confirm the initial validity for a periodic review. Revalidation provides evidence that changes in a process and/or introduced process environment do not adversely affect process characteristics and product quality. The documentation requirements will be the same as for ...
