MCT Beginning T 43

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

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

2. The implementation of the audit program requires:

• Its approval by top management
• Its communication to the concerned parties
• Audit plans to be followed
• Audit follow-up

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 records related to the audits, among other things, contain the:

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

5. An internal audit is initiated, for example:

• When it is scheduled in the audit program
• Following the request of a department manager
• After a dysfunction in an activity
• Following a major evolution of a process