Monday, June 17, 2013

What is SOP?

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.

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