In the past few years eight of the nine chapters of EU GMP have been updated.  However, EU GMP Chapter 9 has not been updated at all.  This is strange as GMP’s stance on Quality Management System thinking has evolved a lot of the past few years, so surely the requirements for the number one mechanism that you have to evaluate this system should be updated too?  Here are my thoughts on what I would include in a future update if I was in charge.

Below the current text is in black and my new suggestions for a revision to EU GMP Chapter 9 are in blue italics.

Title:      Self-inspection

I would change this to Internal Audit.  It is what every other sector uses to describe this activity.

Principle

Self inspections should be conducted in order to monitor the implementation and compliance with Good Manufacturing Practice principles and to propose necessary corrective measures.

I would add “and to promote continual improvement” at the end of this section.

9.1 Personnel matters, premises, equipment, documentation, production, quality control, distribution of the medicinal products, arrangements for dealing with complaints and recalls, and self inspection, should be examined at intervals following a pre-arranged programme in order to verify their conformity with the principles of Quality Assurance.

Change the opening part of this clause to “All parts of the Quality Management System should be examined at intervals …”  The reason for this is to include looking at areas and processes not covered by the current list, such as management commitment, management review, Quality Assurance, Engineering, Purchasing, training, batch review and release, problems, deviations, CAPAs, and so on.  In addition add that areas to be audited should be based on their status and importance.

9.2 Self inspections should be conducted in an independent and detailed way by designated competent person(s) from the company. Independent audits by external experts may also be useful.

This is fine.

9.3 All self inspections should be recorded. Reports should contain all the observations made during the inspections and, where applicable, proposals for corrective measures.  Statements on the actions subsequently taken should also be recorded.

Add to this clause that the report should contain any non-conformities raised.  That these should be dealt with in a timely manner, with the manager of the area responsible for this.  Dates for dealing with non-conformities should be agreed.  Any action taken should get to the root-cause of the problem.

Finally – add two new clauses.

Starting with a new clause (9.4) to include:

The results of audits should be discussed at management review, with any additional resources and expertise allocated as necessary.

And also a new clause (9.5) to include:

In the event of changes or problems in a specific area then this should be considered for additional audits.

I hope that you agree with these thoughts about EU GMP Chapter 9.  Even if not included formally in GMP then you might want to think about embracing these within your own system (if not done so already).  If you need any help with auditor related training then please visit our website for details of our Internal Auditor and Lead Auditor training courses.