WHO training on Good Manufacturing Practices (GMP). Module 2: GMP Inspection Process Lesson 4: The role of the inspector

1. Module 17 | Slide 1 of 9 January 2006
The Role of the Inspector
GMP Inspection Process

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
 manufacture and/or quality control
 Academic qualifications
 pharmacists, chemists, scientists
 pharmaceutical 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
 pharmaceutical technology
 microbiology
 statistical aspects of quality control

5. Module 17 | Slide 5 of 9 January 2006
The Role of the Inspector
Responsibilities
 Detailed factual report
 manufacture and control
 specific products
 Assess GMP compliance
 faults, irregularities, discrepancies
 Advice on improving manufacture and control
 depending on national policy
 must be consistent and available to all
 motivate manufacturer to comply with GMP
 correct 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