During my many years of reviewing and working with CGMP Quality Systems, I have encountered several reoccurring shortcomings. Although a given Quality System is not likely to have all of these shortcomings, most quality systems that I have evaluated have at least one of them.
Nine common CGMP Quality System shortcomings are:
- Narrow-Focused Development Program
- Unrefined Quality Monitoring
- Inundated Quality Systems and Personnel
- An “It’s Approved, Don’t Improve It” Mentality
- Under Utilized Quality Tools
- Poor Quality Leadership from Senior Management
- Resistance to New Technological Advances
- Meager Internal Auditing Program
- Ineffective Training Programs
Over the course of the next nine week’s I will elaborate on each of these Quality System shortcomings and provide suggestions on how to overcome them.
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