1.What is SOP? Why it is needed ?
SOP (Standard Operating Procedure)
A written approved procedure which gives instruction for performing operation not necessarily specific to a given product or material but of a more general matter (e.g. equipment operation, maintenance and cleaning of premises, and environmental and sampling and inspection).
Purposes: To describe the method for writing procedures for all general operations.
2.When and where revalidation 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.
