Some common inspection findings and current areas of concern that have been identified during recent inspections have been included in the following examples.
In this section...
Inspection findings
General examples
(954Kb)
Investigational medicinal products (IMP) manufacture (775Kb)
Active Pharmaceutical Ingredients (API) manufacture (843Kb)
Review of deficiency data from April 2011 - March 2012
The presentation below includes confirmation of the top ten deficiencies and with examples of actual deficiencies found.
April 2011 to March 2012 Deficiency Data Review (2880Kb)
Review of deficiency data from April 2010 - March 2011
The presentation below includes confirmation of the top ten deficiencies and with examples of actual deficiencies found.
April 2010 to March 2011 Deficiency Data Review (806Kb)
Review of deficiency data from April 2010 - December 2010
The presentation below includes conformation of the top five deficiencies with examples of actual deficiencies found.
April 2010 to December 2010 Deficiency Data Review (106Kb)
Review of deficiency data from April 2008 - March 2010
The presentation below includes conformation of the top five deficiencies over a two year period with examples of actual deficiencies found.
April 2008 to March 2010 Deficiency Data Review (107Kb)
Review of deficiency data from April 2008 to March 2009
The attached review includes confirmation of the top five deficiency categories and a breakdown of deficiencies by GMP requirement, site type and sector. The data is designed to enable sites to identify potential issues in a proactive manner and therefore facilitate improvements in GMP compliance.
Review of deficiency figures April 2008 - March 2009 (204Kb)
From April - September 2009
The following presentation includes data on the number of relevant inspections performed and an illustration of the top deficiencies, grouped according to applicable chapters of the 'Orange Guide"' to provide more meaningful data on the classification of deficiencies.
Deficiency database figures April to September 2009
Examples of deficiencies (47Kb)
For September - December 2009
- Number of relevant Inspections (total): 277
- Number of critical deficiencies reported: 20
- Number of major deficiencies reported: 631
Data reviewed from the attached presentation indicates the top five deficiencies as:
- Investigation of anomalies
- Investigation of anomalies - CAPA
- Quality management
- Quality Management - Change Control
- Documentation - Quality System element/procedures/PSF
Deficiency database figures September 2009 – December 2009 (1106Kb)
Deficiency classification
The GMP/GDP Inspectorate has collated data from Post Inspection Letters in order to provide information on the number of critical and major deficiencies reported and identify the top five serious issues from the 40 classifications used.
For 2007/08
- Number of relevant Inspections (total): 598
- Number of critical deficiencies reported: 28
- Number of major deficiencies reported: 838
Data reviewed to date indicates the top five deficiencies:
- Investigation of anomalies
- Documentation (QMS, procedures)
- Quality management
- Supplier audit and technical agreements
- Change control/management
For 2008
- Number of relevant Inspections (total): 369
- Number of critical deficiencies reported: 34
- Number of major deficiencies reported: 793
Data reviewed to date indicates the top five deficiencies:
- Investigation of anomalies
- Quality management
- Quality management (change control)
- Complaints and product recall
- Corrective action/preventive action (CAPA)
For January - March 2009
- Number of relevant Inspections (total): 105
- Number of critical deficiencies reported: 9
- Number of major deficiencies reported: 219
Data reviewed to date indicates the top five deficiencies:
- Investigation of anomalies
- Design and maintenance of facilities
- Quality management (change control)
- Supplier and contractor audits
- Contamination, chemical/physical - potential for
Examples of common inspection deficiencies relating to Qualified Person issues are available below:
Examples of QP Issues (1707Kb)
