The
revised EDQM guideline Content of the dossier for chemical purity and
microbiological quality, PA/PH/CEP (04) 1, 6R will enter into force in January
2019. Changes included in this revised guideline reflect changes in the
regulatory environment since the previous version was implemented in September
2015. These include, for example, the impact of and references to ICH M7
“Assessment and control of DNA reactive (mutagenic) impurities in
pharmaceuticals to limit potential carcinogenic risk”, to ICH Q3D “Elemental
impurities” and to ICHQ11 Questions and Answers.
Other
notable changes include more situations where alternative options cannot be
addressed using a single CEP application and would require a separate CEP
application. Examples of where a new separate CEP application is required
include alternative substantially different routes of synthesis (even when the
impurity profile of the final substance is equivalent) or multiple
manufacturing sites for the final substance which do not belong to the same
group, or use of a material from more than one source where the TSE risk is
different for the different sources.
Applicants
are strongly encouraged to read the revised guideline as some of the changes
may impact their regulatory strategy for CEP applications they intend to submit
during 2019.
See:
EDQM https://www.edqm.eu/sites/default/files/policy_document_-_content_of_the_dossier_for_chemical_purity_and_microbiological_quality_-_november_2018.pdfPosted by Dr. Tim Sandle, Pharmaceutical Microbiology
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