📋 Types of Audits in the Pharmaceutical Industry

1. Internal Audit (Self-Inspection)

• Purpose: To assess compliance with internal SOPs and GMP requirements.

• Conducted By: Company’s own QA or compliance team.

• Frequency: Regularly scheduled (e.g., annually or quarterly).

• Use: Identify gaps and continuously improve internal systems.

2. External Audit

• Purpose: Evaluation of a third-party organization (e.g., suppliers or contractors).

• Subtypes:

  • Supplier Audit / Vendor Audit: Audits of raw material or service providers to ensure quality and GMP compliance.

  • Contract Manufacturer Audit: Ensures contract facilities meet regulatory and product-specific requirements.

• Conducted By: The sponsoring or contracting pharmaceutical company.

3. Regulatory Audit (Inspection)

• Purpose: To ensure compliance with regulatory laws and guidelines.

• Conducted By: Health authorities (e.g., FDA, EMA, MHRA, TGA).

• Examples:

  • Pre-approval inspections

  • Routine surveillance inspections

  • For-cause inspections

4. For-Cause Audit

• Purpose: Triggered by specific events like product complaints, deviations, or regulatory findings.

• Use: Investigate root causes and assess compliance in targeted areas.

5. Follow-Up Audit

• Purpose: To verify that corrective and preventive actions (CAPAs) from previous audits have been implemented effectively.

• Conducted After: Internal, external, or regulatory audits with significant findings.

6. System-Based Audit

• Purpose: Focused on specific quality systems like:

  • Documentation control

  • Validation

  • Change control

  • Equipment calibration

  • Data integrity

7. Product or Process Audit

• Purpose: To evaluate the specific manufacturing process or product line for GMP compliance and quality assurance.