Course Code: ELM-122-09

Key Process Principles of GMP Audits

Principles relating to audit process include:

Independence

Auditors must:

  • Be independent of the activity being audited
  • Be free from bias and conflict of interest
  • Maintain an objective state of mind throughout the audit process
  • Ensure that audit findings and conclusions will be based only on the audit evidence

Evidence Based Approach

The audit evidence must:

  • Be verifiable
  • Be based on samples of the information available
  • Ensure that proper use of sampling is made, to contribute to the confidence that can be placed on the audit conclusions

Author

Joginder Mittal

Manager - Quality Compliance Glatt Pharma Engineering