GMP Cosmetic Audit in Europe

Are you sure your cosmetic manufacturing truly follows EU rules? An internal audit is the most effective way to confirm that your processes, documentation, and operations comply with EU Regulation 1223/2009 and, where applicable, GMP principles—and Sobel is here to guide you through every step.

For who?

With Sobel as your partner, a GMP cosmetic audit in Europe becomes an opportunity to identify gaps, strengthen systems, and prepare for inspections with confidence.

Why do you need this service?

An internal audit gives your company the opportunity to confirm whether internal practices are truly aligned with EU Regulation 1223/2009 and GMP principles

By detecting documentation gaps or process weaknesses early, your business reduces the risk of regulatory warnings, product recalls, or barriers to market entry.

Structured feedback from a specialized audit helps your team continuously improve processes and build a solid foundation for sustainable growth in Europe.

GMP cosmetic audits that turn compliance into confidence.

With Sobel as your partner, a GMP cosmetic audit in Europe becomes a structured path to detect risks early, improve documentation, and strengthen compliance practices across your organization.

Stronger systems, smoother inspections, safer market entry.

Remote or On-Site

Your company decides whether the audit will take place remotely or on-site.

Audit Planning

We define the scope and activities of the audit, based on your regulatory framework and internal structure.

Documentation Review

We check the completeness and conformity of SOPs, quality manuals, product files, and regulatory records.

Implementation Assessment

We verify if procedures are being applied consistently across teams and operations.

Audit Report

You receive a detailed report with results, identified non-conformities, and clear recommendations for improvement.

Related
Services

Get a complete solution to close compliance gaps, reinforce your systems, and ensure readiness for EU inspections.

In addition to GMP cosmetic audits, Sobel supports cosmetics companies with:

Supplier Audit and Qualification

Ensure compliance and quality across your supply chain.

PIF - Product Information File

Review and preparation of Product Information File (PIF) for regulatory compliance.

Cosmetic Product Safety Report

CPSR preparation in compliance with EU Regulation (EC) No. 1223/2009 for cosmetic product safety.

Strengthen your compliance with Sobel audits

With Sobel as your partner, a GMP cosmetic audit in Europe becomes an opportunity.

Whether online or on-site, we help your team identify risks, reinforce compliance, and prepare for future inspections with confidence.

Still have questions? Checkout our FAQ

1. What is the purpose of a GMP cosmetic audit?

A GMP cosmetic audit helps verify whether your company’s procedures, documentation, and operations are in line with EU Regulation 1223/2009 and, when applicable, Good Manufacturing Practices (GMP). It is a proactive way to detect gaps and prepare for inspections before issues arise.

2. What is the difference between an internal and an external audit?

An internal audit is commissioned by your company to review processes, detect gaps, and prepare for compliance. An external audit is usually conducted by certification bodies or authorities to officially verify conformity. Sobel offers internal audits that help you be ready for any external inspection.

3. Can international companies outside the EU request this audit?

Yes. Even if your cosmetics are manufactured outside the European Union, they must comply with EU 1223/2009 and GMP before entering the market. Our audits support both EU-based manufacturers and international companies aiming for European market access.

4. Can I choose between a remote and an on-site audit?

Yes. Your company decides the format that best fits your needs. Remote audits are practical for documentation reviews or distributed teams, while on-site audits provide a deeper verification of facilities and processes.

5. What happens if non-conformities are found?

If non-conformities are identified, they will be listed in the audit report with recommendations. A new proposal can then be prepared to support your company in addressing and correcting these issues.