Formats of Pharmaceutical Audits

1. On-Site Audit (Physical Audit)

   • Conducted at the manufacturing site, laboratory, warehouse, or supplier facility.

   • Provides direct observation of processes, equipment, and personnel.

   • Most common format for GMP compliance checks.

2. Remote Audit (Virtual Audit)

   • Conducted using digital tools (video conferencing, document sharing platforms).

   • Gained popularity during COVID-19 restrictions.

   • Useful when travel is not feasible, though limited in physical verification.

3. Desktop / Documentation Audit

   • Focuses only on reviewing documents, records, and quality systems without a site visit.

   • Often used for preliminary assessments or follow-ups.

4. Hybrid Audit

   • Combination of on-site and remote methods.

   • Balances physical inspections with digital document reviews.

5. First-Party Audit (Internal Audit)

   • Conducted by the company itself to ensure compliance with internal SOPs and GMP.

6. Second-Party Audit

   • Conducted by a company on its suppliers, vendors, or contractors.

   • Ensures supply chain compliance.

7. Third-Party Audit

   • Carried out by regulatory bodies (FDA, EMA, WHO) or independent certification agencies (ISO audits).

   • Most formal and legally binding.