Follow
SOPs are detailed written instructions for the operations routinely performed in the course of any activities associated with pharmaceutical manufacturing.
Or
A written authorized procedure which gives instructions for performing operations not necessarily specific to a given product / material, but of a more general nature the equipments preventive maintenance and cleaning; recall of products; purchasing; cleaning of premises and environmental control; sampling and inspection etc.
Or
These are guidelines which describe how the activity is to be performed. To achieve uniformity of results by each individual, it is mandatory to follow these guidelines. SOP is like a “TELL and SHOW” concept.
Tell – means to establish and teach how the activity is to be carried out.
Show – means to provide the documented proof for the activity carried out.
What are the contents of the SOP?
Objective/Purpose, Scope, Responsibility, Accountability, Procedure, List of formats/Annexure, Abbreviations, Reference, Revision History
