EMA to clarify acceptability of multi-product plants in guidance
Drafting guidance on the toxicological assessment needed to determine if multiple products can be manufactured in a single facility will clarify existing good manufacturing practices (GMPs). Full details are yet to be developed by the European Medicines Agency (EMA) but an outline is in place.
“The agreed approach should be scientifically based and aim to limit variability in deriving acceptable exposure limits thereby ensuring consistency”, the EMA Safety Working Party wrote in a concept paper.
Work on the topic began in 2005 but since then the GMP/GDP Inspectors Working Group at the EMA has recognised the need for a toxicological evaluation to be part of the risk assessment. This part of the process was referred to the Safety Working Group which has now released a concept paper.
The Safety Working Group notes that sometimes toxicological data is excluded from decisions on cross contamination limits. In other cases an arbitrary limit, such as 10 parts per million, is used for cleaning validation. These limits may be too restrictive, or not restrictive enough.
Using science
A more scientific approach is planned. The draft guidance, due for release in June 2012, will use pharmacological and toxicological information to set thresholds as part of quality risk management.
By agreeing on an approach the EMA hopes to stop different production requirements arising. Without a harmonised European policy the EMA fears pharmaceutical manufacturers will face “significant financial impact” and product quality may be compromised.
When draft guidance is published in June a three month consultation period will begin. Comments will be considered before the final text is published in March 2013 with a six month implementation deadline.
