Gmp inspection process
Download
1 / 9

GMP Inspection Process - PowerPoint PPT Presentation


  • 146 Views
  • Updated On :

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.

loader
I am the owner, or an agent authorized to act on behalf of the owner, of the copyrighted work described.
capcha
Download Presentation

PowerPoint Slideshow about 'GMP Inspection Process' - leverett


An Image/Link below is provided (as is) to download presentation

Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author.While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server.


- - - - - - - - - - - - - - - - - - - - - - - - - - E N D - - - - - - - - - - - - - - - - - - - - - - - - - -
Presentation Transcript
Gmp inspection process l.jpg
GMP Inspection Process

The Role of the Inspector

Part One, 12.1–12.11


The role of the inspector l.jpg
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 inspector3 l.jpg
The Role of the Inspector

Qualifications

  • Training

  • Practical experience

    • manufacture and/or quality control

  • Academic qualifications

    • pharmacists, chemists, scientists

    • pharmaceutical industry background


The role of the inspector4 l.jpg
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


The role of the inspector5 l.jpg
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


The role of the inspector6 l.jpg
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


The role of the inspector7 l.jpg
The Role of the Inspector

Communication Skills

  • Language

  • Body language

  • Company history and policy


The role of the inspector8 l.jpg
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


The role of the inspector9 l.jpg
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


ad