1. Module 17 | Slide 1 of 9 January 2006 Part One, 12.1–12.11 GMP Inspection Process The Role of the Inspector

2. Module 17 | Slide 2 of 9 January 2006 The Role of the Inspector Objectives 1. To discuss the ideal qualities of an inspector 2. To review the various roles of an inspector 3. To discuss the basic rules of communication

3. Module 17 | Slide 3 of 9 January 2006 The Role of the Inspector Qualifications Training Practical experience ämanufacture and/or quality control Academic qualifications äpharmacists, chemists, scientists äpharmaceutical industry background

4. Module 17 | Slide 4 of 9 January 2006 The Role of the Inspector Training In-post training Accompany experienced inspectors Regular update of knowledge Courses and seminars äpharmaceutical technology ämicrobiology ästatistical aspects of quality control

5. Module 17 | Slide 5 of 9 January 2006 The Role of the Inspector Responsibilities Detailed factual report ämanufacture and control äspecific products Assess GMP compliance äfaults, irregularities, discrepancies Advice on improving manufacture and control ädepending on national policy ämust be consistent and available to all ämotivate manufacturer to comply with GMP äcorrect specific deficiencies

6. Module 17 | Slide 6 of 9 January 2006 The Role of the Inspector Personal Qualities Conform to codes of ethics and conduct Independent/no conflict of interest No double role as inspector and consultant Resist attempts to influence decisions Discreet

7. Module 17 | Slide 7 of 9 January 2006 The Role of the Inspector Communication Skills Language Body language Company history and policy

8. Module 17 | Slide 8 of 9 January 2006 The Role of the Inspector Group Session For the situation that your group is allocated: 1.List inappropriate behaviour of an inspector 2.Identify what cultural and/or social difficulties might be encountered 3. List some implications for inappropriate behaviour of: 1. The inspector 2. The company being inspected

9. Module 17 | Slide 9 of 9 January 2006 The Role of the Inspector Possible Situations 1. A new company or new factory with licence applications in the pipeline 2. A company with a history of problems 3. A local company on its third inspection, with no major non- compliance but some minor defects and uncertainty about how to improve standards 4. An established company with a good history and trained personnel which is planning to build a new factory and needs support on the design 5. A multinational company with world-class standards