SOPs define how a company will meet GMP requirements. SOPs are your company’s internal regulations; their role is to describe departments’ roles, responsibilities and activities. SOPs are written documents that describe in detail, step-by-step, how a procedure, task, operation or function should be done. SOPs are intended to standardize the performance of the procedure to ensure consistent outcome or results each time. Once established, SOPs should be followed as written as they are intended to describe the company-approved method for performing the procedure, task, operation or function. Changes to SOPs should be made under a change control program that includes a review of the impact of the change(s) and approval by appropriate management and the Quality Unit.
