Hi all,
Even though I still do not have experience in Validation, but I think that a type of Validation could also be Revalidation.
Revalidation means repeating the original validation effort or any part of it, and includes investigative review of existing performance data. This approach is essential to maintain the validated status of the plant, equipment, manufacturing processes and computer systems. Possible reasons for starting the revalidation process include:
-The transfer of a product from one plant to another.
-Changes to the product, the plant, the manufacturing process, the cleaning process, or other changes that could affect product quality.
-The necessity of periodic checking of the validation results.
-Significant (usually order of magnitude) increase or decrease in batch size.
-Sequential batches that fail to meet product and process specifications.
-The scope of revalidation procedures depends on the extent of the changes and the effect upon the product.