Welcome to the European GMP-Auditor Association

Why a GMP-Auditor Association?

The GMP-auditor has a central function within the pharmaceutical quality assurance system. Until today, there was no representation of interests for this important function holder. The ECA Foundation closes a gap here.

The new interest group is also intended to promote dialogue between the GMP-auditors of the various companies.

Establishing such as an interest group for GMP (Good Manufacturing Practice) auditors in the pharmaceutical industry can bring several benefits to both the auditors themselves and the overall quality assurance system:

1. Professional Development and Networking:

    • Providing a platform for GMP auditors to connect, share experiences, and learn from each other.
    • Enhancing the skills and knowledge through conferences and training courses.

2. Information Exchange:

    • The group can serve as a hub for the exchange of information and best practices.
    • A regular newsletters, to keep auditors informed about the latest trends and developments in GMP.

3. Advocacy and Representation:

    • Developing guidelines and recommendations can help harmonize auditing processes across different organizations.
    • The interest group can advocate for the interests and concerns of GMP-auditors at various levels, including with regulatory bodies and industry associations.
    • Representing a unified voice can have a stronger impact in discussions related to regulatory policies and industry standards.

Establishing and maintaining an interest group for GMP-auditors requires commitment, active participation, and effective leadership. By working together, GMP-auditors can contribute to the continuous improvement of pharmaceutical quality assurance and ensure the safety and efficacy of pharmaceutical products.

Upoming Event:

A new ECA Forum to foster Discussions and mutual Exchange in small Working Groups

Highlights:

      • Presentations:
        • ECA’s GMP Auditors Reference Handbook
        • Current Developments
        • Auditor Training
        • Inspector Preferences
      • Round Table Discussions:
        • Information Gathering
        • Special Challenges
        • Checklists
        • Interpreters
        • Supplier Qualification (Consequences of the Chinese Anti-Espionage Law)
        • Difficult Auditees

Contact

Contact us

If you have any questions or suggestions, please contact us. We will be happy to help you with your concerns.

For postal mail please use the following address:
ECA Foundation
attn. European GDP Association
P.O. Box 102168
69011 Heidelberg, Germany

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