If Today an FDA auditor arrives unannounced to your Pharmaceutical Plant, there is a 54.1% chance that you will be receiving a dreaded 483 with a list of observations. You will find here:
5 FDA Observations:
1.Observation for Training.
2.Observation for Facilities and Equipment.
3.Observation for Quality systems
4.Observation for Production Systems.
5.Observation for Cleaning Validation
This concise book provides an introduction to Current Good Manufacturing Practices (aka cGMP). It introduces those who wish to work in regulated industries to GMP, highlighting key areas and practices. It is also a useful refresher for those with previous experience of cGMP. At less than 90 pages, it is a short but useful reference or refresher guide - perfect for introducing new people to cGMP cu