EMEA Issues Statement on Status of Revision of GMP Guide Concerning "Dedicated Facilities"

GMP News
21 February 2008

EMEA Issues Statement on Status of Revision of
GMP Guide Concerning "Dedicated Facilities"

A concept paper published as early as in 2005 announced changes to Chapter 3.6 and 5.18 intended to remove the still existing ambiguity. Chapter 3.6 mentions, for example, "certain" products that should not be manufactured in the same production facility. This means that a dedicated facility is mandatory. The text also mentions "exceptional cases" without defining either these or the "certain" products.

The concept paper dating back to 2005 gives these missing definitions. Besides, the drafting group agreed with the GMP/GDP Inspectors Working Group that the necessary revision of the above-mentioned chapters should take the principles of ICH Q9 (Quality Risk Management) into account. However, since then it has remained unclear whether there will be a substance category for whose manufacture a dedicated facility is mandatory or whether it will be possible for the industry to decide autonomously and by relying on a scientifically-based risk analysis if the facility in question should be dedicated or not.

The lively discussion about this subject prevented the revision of the guide from being completed on schedule. Due to the great interest, EMEA has now published an intermediate report on the state of the revision.

This report says that the GMP/GDP Inspectors Working Group is unanimous that there will be a list of substances for which a dedicated facility is mandatory. According to the report, the pharmacological and toxicological expertise necessary for compiling this list "has now been made available". Here, the text does not give any further details.

For other products it shall be possible to base this decision on a risk analysis. Still, substances representing a great risk both with regard to their physico-chemical characteristics and with regard to their pharmacological/toxicological properties will also have to be manufactured in dedicated facilities unless the contrary can be demonstrated by means of Quality Risk Management and suitable risk-reducing measures.

The drafting group is currently developing a table meant to define in detail a great physico-chemical risk.

The revised chapters of the GMP Guide are planned to be submitted to the European Commission at the end of 2008; public consultation can be expected to start at the beginning of 2009.

The EMEA statement can be found here:

The European Compliance Academy (ECA) will hold a containment conference in Vienna from 30 September to 1 October 2008. The programme will be finalised in April 2008.

Dr Robert Eicher
On behalf of the European Compliance Academy (ECA)

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