What is SOP?
Standard Operating Procedure: documented, version-controlled instructions for carrying out routine operations. SOPs in compounding require author, reviewer, and approver signatures per 21 CFR Part 11.
An SOP is only useful if the version staff follow is the version quality approved. That requires lifecycle control: drafts, review and approval signatures, an effective date, staff acknowledgment that they read the current edition, periodic review, and preserved history of superseded versions.
'SOP not followed' and 'SOP does not reflect actual practice' are perennial inspection observations — which is why acknowledgment tracking and review scheduling matter as much as the document text.
See how CompliRx handles this in practice:
Document control softwareRelated terms
Turn the standard into daily records
CompliRx helps compounding pharmacies keep environmental monitoring, qualifications, cleaning, documents, and CAPA evidence inspection-ready.