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GMP Inspection Process

GMP Inspection Process. The Role of the Inspector. Part One, 12.1–12.11. 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. The Role of the Inspector.

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GMP Inspection Process

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  1. GMP Inspection Process The Role of the Inspector Part One, 12.1–12.11

  2. 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. The Role of the Inspector Qualifications • Training • Practical experience • manufacture and/or quality control • Academic qualifications • pharmacists, chemists, scientists • pharmaceutical industry background

  4. 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. 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. 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. The Role of the Inspector Communication Skills • Language • Body language • Company history and policy

  8. 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. 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

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