MCT Beginning T 43

1. 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

2. 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

3. 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

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. The objectives of an audit program are influenced by:

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