MCT Beginning T 43

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

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

2. The objectives of an audit program are influenced by:

• Quality procedures
• Expectations of top management
• GMP requirements
• Applicable regulatory requirements
• Risks identified

3. 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

4. The audit report often contains:

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

5. 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