Certification

what is apic certification

The APIC Auditor Certification – how does it work?

If you aim to obtain the APIC Auditor Certification you have to complete one of the Compliance Courses and the Auditor Training Course.

PLEASE NOTE. APIC has updated the requirements to be fulfilled by aspiring APIC Certified Auditors.

Prerequisites to become an APIC Certified ICH Q7 Auditor

I n order to become an APIC Certified auditor the following prerequisites have to be fulfilled:

  • You should have at least 5 years practical experience of GMP compliant manufacture in the pharmaceutical industry or API industry
  • You should already have conducted at least 10 external audits in the last 3 years. At least 1 audit per year should have been related to APIs, Intermediates or Starting Materials with ICH Q7 as standard
  • You have to complete one of the Compliance Courses before you take part in the Auditor Training Course.
  • You have to pass a written exam directly after the Auditor Training Course
  • You also have to pass an Internet-based exam appr. two weeks after the Auditor Training Course

This APIC certification is an option and not

mandatory for the participation in these courses.

The APIC Auditor Certification – when does it expire and how to re-certify?

The auditor’s certification is valid for 3 years .

The certification can be extended for another 3 years provided

  • you have attended at least two training course/conference on current GMP topics during the current period of certification and
  • you have satisfactorily performed at least three audits during the current period of certification and
  • you have taken another internet-based test at the time of your next re-certification.

If either of these conditions is not met, your name will be withdrawn from the register of APIC Certified Auditors kept by the API Compliance Institute.

The API Compliance Institute keeps a register of all APIC Certified auditors.

What is the API Compliance Institute?

The API Compliance Institute as a Business Unit of Concept Heidelberg and has been contracted by APIC to administer the APIC Third Party Audit Programme.

If you are not sure whether you should apply for this optional certification, please contact Dr Gerhard Becker, phone +49 (0)62 21 84 44 65, email: becker@api-compliance.org.

Source: www.ichq7a.org

Category: Insurance

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