Course Code: ELM-122-08

Key Principles of GMP Audits for Auditors

Observance of the key principles is a prerequisite for providing a reliable and relevant audit outcome.  GMP Auditors must adhere to the following principles and attributes, based on ISO 19011.

Principles relating to auditors include:

Ethical Conduct

It includes auditor behavior that reflects trust, integrity, confidentiality and discretion.

Fair Presentation

The obligation to describe truthfully and accurately:

  • Audit activities through – audit findings, conclusions and reports
  • Significant problems encountered
  • Unsettled diverging opinions between auditee and audit team

Due Professional Care

  • The application of diligence and judgment in auditing.
  • Reasonable care in all matters and the completeness of the audit report avoiding errors that may endanger any of these auditing principles.

Author

Joginder Mittal

Manager - Quality Compliance Glatt Pharma Engineering