MCT Beginning T 43

1. Improving the audit program takes into account the:

• Rate of implementation of the audit plan
• Percentage of trained persons as internal auditors
• Trends of audits
• Proper application of procedures

2. The records related to the audits, among other things, contain the:

• Audit plan
• Audit report
• Audit procedure
• Evaluation of auditor competence
• Audit team members

3. The extent of the audit program, among other things, depends on:

• Process complexity
• Risks identified
• Follow-up of previous audits
• Commercial policy
• Essential characteristics of products

4. The results of the process internal audit:

• Are management review outputs
• Are management review inputs
• Allow GMP improvement opportunities to be found
• Are verifiable evidences

5. The audit report often contains:

• Audit findings
• Auditor opinions
• Audit conclusions
• Auditor proposals
• Identified good practices