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