Industry news

EMA Shared Facilities Concept Paper

In February 2005 the EMA published a Concept Paper on the topic of the need for ‘dedicated facilities’ for certain highly potent or sensitising drugs, to clarify the requirements given in Chapter 3, Section 6, of the EU GMP Guide. The Concept Paper proposed revising Chapter 3, Section 6, together with Chapter 5, Section 19 (which deals with cross-contamination) to clarify when dedicated facilities are required.

In October 2011 the EMA CHMP published a new Concept Paper on this subject entitled “the development of toxicological guidance for use in risk identification in the manufacture of different medicinal products in shared facilities” with comments being due by 31 January 2012.

The October 2011 Concept Paper problem paper states:-

“At present there is no defined approach in order to outline a method of deriving acceptable exposure limits for cross contamination between products manufactured using shared facilities. The concern arises that in the absence of any guidance and with a plethora of toxicological tools being available a lack of harmonised interpretation could occur both in pharmaceutical industry and National Competent Authorities. This may result in different production requirements with significant financial impact on manufacturers and potentially, in medicinal products of impaired quality which may adversely affect patients’ health”

It goes on to state:

“A more scientific approach based on current available pharmacological and toxicological information is required to establish threshold values to be used as part of the overall Quality Risk Management in shared facilities.”

“The Safety Working Party recommends drafting new guidance on toxicological assessment to be used in the risk identification stage of the Quality Risk Management process in determining whether a medicinal product should be manufactured in dedicated facilities. More specifically the agreed approach should be scientifically based and aim to limit variability in deriving acceptable exposure limits thereby ensuring consistency.”

The recommendation made by the October 2011 Concept Paper would appear to be in alignment with the ISPE ‘Baseline Guide’ on the subject of ‘Risk-Based Manufacture of Pharmaceutical Products (RISK-MaPP)’ that was published in September 2010.

The time table for progressing this issue is given in the Concept Paper as follows:

• Draft guidance to be published for a 3 month consultation in June 2012.

• Final guidance to be published in March 2013 with a 6 month implementation deadline.

Given that we had over six years of discussion and inaction following the publication of the 2005 concept paper, this timetable is probably a little ambitious but we will have to wait and see.