MCT Beginning T 43

1. The audit procedure contains, at minimum, instructions on how to:

• Plan the audits
• Conduct the audits
• Ensure auditor competence
• Assign the responsibility for managing the audit program to a qualified person

2. 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

3. The audit report often contains:

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

4. 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

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

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