Module 17 | Slide 1 of 9 January 2006

Part One, 12.1–12.11

GMP Inspection ProcessGMP Inspection Process

The Role of the Inspector

Module 17 | Slide 2 of 9 January 2006

The Role of the InspectorThe 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

Module 17 | Slide 3 of 9 January 2006

The Role of the InspectorThe Role of the Inspector

Qualifications

Training

Practical experience manufacture and/or quality control

Academic qualifications pharmacists, chemists, scientists pharmaceutical industry background

Module 17 | Slide 4 of 9 January 2006

The Role of the InspectorThe 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

Module 17 | Slide 5 of 9 January 2006

The Role of the InspectorThe 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

Module 17 | Slide 6 of 9 January 2006

The Role of the InspectorThe 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

Module 17 | Slide 7 of 9 January 2006

The Role of the InspectorThe Role of the Inspector

Communication Skills

Language

Body language

Company history and policy

Module 17 | Slide 8 of 9 January 2006

The Role of the InspectorThe 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

Module 17 | Slide 9 of 9 January 2006

The Role of the InspectorThe 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