Expand Document | Expand Chapter | Full TOC | Printable HTML version
WHO Basic Training Modules on Good Manufacturing Practices (GMP) - GMP Inspection Process: Module 2 (Part 05): The Inspection
(2006; 35 pages)
Table of Contents
View the documentGMP Inspection Process
View the documentThe Inspection
View the documentThe Inspection
View the documentThe Inspection
View the documentThe Inspection
View the documentThe Inspection
View the documentThe Inspection
View the documentThe Inspection
View the documentThe Inspection
View the documentThe Inspection
View the documentThe Inspection
View the documentThe Inspection
View the documentThe Inspection
View the documentThe Inspection
View the documentThe Inspection
View the documentThe Inspection
View the documentThe Inspection
View the documentThe Inspection
View the documentThe Inspection
View the documentThe Inspection
View the documentThe Inspection
View the documentThe Inspection
View the documentThe Inspection
View the documentThe Inspection
View the documentThe Inspection
View the documentThe Inspection
View the documentThe Inspection
View the documentThe Inspection
View the documentThe Inspection
View the documentThe Inspection
View the documentThe Inspection
View the documentThe Inspection
View the documentThe Inspection
View the documentThe Inspection
View the documentThe Inspection
 

The Inspection

Group Session 1

  • You will be given a situation about which you have to determine the factual information regarding the situation. The people being inspected will be truthful, but will not volunteer any extra information

  • List up to 5 questions that you would ask in order to obtain the information that you require

We will now have our first group discussion.

Each group will be given a situation that you could be faced with during an inspection. You need to work out what questions you would ask in order to get the information you need.

To make it close to real life, we have said that the people being inspected will be truthful in their answers (and in most inspections, you will find that this is so). However, they will not volunteer information that you do not ask for.

(Trainers will need to develop appropriate situations, based on the prior knowledge and experience of the trainees. Possible issues: Establish whether raw materials are sampled and tested in accordance with the specifications and SOPs, establish whether proper training is given to employees in production and quality control, establish whether validation had been performed on the HVAC system. Following the feedback session on these group discussions, move on to the next presentation.)

to previous section to next section
 

Last updated: May 3, 2013