In the pharmaceutical industry, quality audits are critical for ensuring compliance with Good Manufacturing Practices (GMP), regulatory guidelines, and internal quality standards. The main types of audits include:

Types of Quality Audits in Pharma

1. Internal Audit (Self-Inspection)

   • Conducted by the company’s own quality assurance team.

   • Ensures compliance with SOPs, GMP, and internal policies.

2. External Audit (Second-Party Audit)

   • Performed by a company on its suppliers, contract manufacturers, or service providers.

   • Evaluates compliance with agreed standards and quality requirements.

3. Regulatory Audit (Third-Party / Regulatory Authority Audit)

   • Conducted by regulatory bodies (e.g., FDA, EMA, MHRA, WHO).

   • Ensures compliance with regional and international regulations.

4. Supplier/ Vendor Audit

   • Focused specifically on evaluating raw material suppliers, API manufacturers, packaging suppliers, etc.

   • Ensures material quality and reliability of supply chain.

5. For-Cause Audit

   • Triggered by a specific event, deviation, complaint, or suspected non-compliance.

   • Targeted and detailed investigation.

6. Certification Audit

   • Conducted by third-party certifying bodies.

   • Assesses compliance with standards like ISO 9001, ISO 13485, ISO 14001.

7. Follow-Up Audit (Re-Audit)

   • Done after a previous audit to verify corrective and preventive actions (CAPA) have been implemented effectively.

8. Routine / Scheduled Audit

   • Regularly planned audits based on audit schedules.

   • Preventive approach to maintain compliance and continuous improvement.