Pharmaceutical companies carry out various types of audits to ensure compliance with the European Union (EU) Good Manufacturing Practice (GMP) regulations. Here are some of the different types of EU GMP audits commonly conducted by pharma companies:

1. Self-Inspection/Internal Audit

This is an internal audit conducted by the pharmaceutical company itself. It involves assessing the company’s compliance with GMP regulations, evaluating the effectiveness of quality systems, and identifying areas for improvement. Self-inspections are an integral part of a company’s quality management system.

2. External Supplier/Vendor Audit

Companies perform audits of their suppliers and vendors to evaluate their compliance with GMP regulations. These audits assess the quality systems, manufacturing processes, and documentation practices of the external entities to ensure that they meet the required standards for the supply of materials, components, or services.

3. Regulatory Authority Inspection

Regulatory authority inspections are conducted by competent authorities, such as the European Medicines Agency (EMA) or national regulatory agencies, to assess a pharmaceutical company’s compliance with GMP regulations. These inspections are typically scheduled and may be routine or triggered by specific events, such as new product approvals or changes in manufacturing sites.

4. Pre-Approval Inspection (PAI)

A PAI is conducted by regulatory authorities before granting marketing authorization for a new pharmaceutical product. The inspection ensures that the manufacturing facility and processes comply with GMP standards and are capable of consistently producing products that meet the required quality, safety, and efficacy criteria.

5. GMP Compliance Audit by Customers

Pharmaceutical companies may be subject to audits conducted by their customers, such as wholesalers, distributors, or contract manufacturing organizations (CMOs). These audits verify compliance with GMP requirements and may also focus on specific contractual or quality agreements.

6. Mock Inspections

Mock inspections are practice audits conducted internally or by third-party consultants to simulate regulatory authority inspections. These audits help identify gaps in compliance, assess readiness for actual inspections, and improve the company’s response to regulatory authority requirements.

It’s important to note that the specific types of audits conducted may vary based on the size of the pharmaceutical company, the complexity of operations, the nature of products, and regulatory requirements. The goal of all these audits is to ensure compliance with EU GMP regulations, maintain product quality, and uphold patient safety.

MIAS has a global network of auditors that are available to carry out on site, virtual and on site audits on your behalf should you require support. For more information on how we can help please contact us here.

Alternatively, have a look at the video below to learn more about audit preparation from an auditor’s perspective.


What is involved in the preparation of an Audit