What Is the Difference Between an Audit and Inspection in the Pharmaceutical Industry?

Aspect	Audit	Inspection
Definition	A systematic, independent review to assess compliance with internal or external standards (e.g., GMP).	A formal review by a regulatory authority (e.g., FDA, EMA) to ensure compliance with laws and regulations.
Conducted By	Internal quality teams or external third-party auditors.	Regulatory agencies (e.g., FDA, MHRA, EMA).
Purpose	To evaluate internal controls, SOP adherence, and preparedness.	To verify regulatory compliance and product safety/quality.
Scope	Can be broad or focused (e.g., only documentation or manufacturing).	Typically comprehensive; may involve facility, process, and records.
Frequency	Scheduled periodically or triggered by internal need.	Usually unannounced or scheduled by the regulatory body.
Consequence	Internal corrective/preventive actions (CAPA).	Potential regulatory action (e.g., warning letter, fines, product recall).
Documentation	Audit report shared internally or with the audited entity.	Inspection report (e.g., FDA Form 483) issued by the authority.

Audit: A pharmaceutical company conducts an internal audit of its QC lab to ensure GMP compliance.
Inspection: The FDA inspects a manufacturing facility to verify compliance before approving a new drug.

Audit = Internal or third-party evaluation.
Inspection = Government regulatory review.
Both are essential for ensuring compliance, product quality, and patient safety.