Revalidation in Pharmaceuticals

When and where re-validation is required?

Revalidation means that the original validation program should be repeated at a predetermined frequency. This work is carried out 3 years interval & any change of critical steps or process.

i.             Changes in raw materials (Physical parameters such as viscosity, density, moisture & Particle size distribution) may affect the products & process

ii.            Changes in the sources of active raw materials manufacturer

iii.            Changes in the packaging materials (Primary packaging/Closure system)

iv.            Changes in the processes (e.g. mixing time, dry time, drying temp.& batch size)

v.            Changes in the equipment (e.g. addition of automatic electric system)

vi.            Changes in the plant or facility

vii.            Variation revealed by trend analysis.