Internal audit acts as the organizations eyes and ears to collect feedback for modification and improvement.
Principle 1
- To ensure that a company’s operations remain compliant with GMP
- To identify possible product / process improvements
- To identify deficiencies in products or in the plant/quality management system
- To foster continuous improvement and forward quality
Principle 2
Special occasions may demand additional self-inspections
For example:
- Recalls
- Repeated rejections
- GMP inspections announced by the National Drug Regulatory Authority
Principle 3
- The team should consist of personnel who can evaluate the situation objectively
- There should be no conflict of interest
- There should be no revenge in mind
- Personnel should have experience as observers of a self-inspection team before becoming team member
- The lead self-inspector should have prior experience as team member
Goals of Internal Audits
Internal audits should:
- Cover all aspects of production QC and QA
- Be designed to detect shortcomings in the implementation of GMPs
- Recommend corrective action if shortcomings are observed
- Set a timetable for corrective actions to be completed