What Is The Revalidation Criterion For Process Validation?

1.	What Is The Revalidation Criterion For Process Validation?
Answer» CHANGE in formulation, procedure or quality of PHARMACEUTICAL ingredients. Change of equipment, addition of new equipment and major breakdowns/maintenance, which AFFECT the performance of equipment. Major change of process, parameters. Change in manufacturing site. On appearance of negative quality TRENDS. On appearance of new findings based on current knowledge. Batch SIZE change.

Answer»

CHANGE in formulation, procedure or quality of PHARMACEUTICAL ingredients.
Change of equipment, addition of new equipment and major breakdowns/maintenance, which AFFECT the performance of equipment.
Major change of process, parameters.
Change in manufacturing site.
On appearance of negative quality TRENDS.
On appearance of new findings based on current knowledge.
Batch SIZE change.

Discussion