The EMEA recently revamped its webpage on inspections (http://www.emea.eu.int/Inspections/index.html ). This is a valuable repository of information on EMEA's current inspection and associated activities and provides valuable insight into its thinking on specific inspection-related issues.
Recently it has discussed two documents dealing with aspects of manufacturing which have been of significant interest over the last few years. The first, "A reflection paper on the chemical, pharmaceutical and biological information to be included in dossiers when Process Analytical Technology (PAT) is employed" (http://www.emea.eu.int/Inspections/docs/PATGuidance.pdf), relates to instances when companies chose to use the PAT approach in marketing authorisation applications for products. It sets out the Inspectorates" thoughts on what data need to be provided in support of such applications.
The Agency points out that this paper represents preliminary recommendations and not formal guidance and invites comments from interested parties. There is no formal consultation date as practice in this area will be a process of evolution for some time; nonetheless, the paper gives an early indication of Inspectorate thinking and provides a welcome opportunity for companies to express their views.
The second paper gives guidance on handling minor deviations from the detail described in the marketing authorisation (http://www.emea.eu.int/Inspections/docs/QPdiscretion.pdf). This document discusses the action that may be taken in cases where there is a one-off deviation from the detail of the manufacturing process and/or the analytical technology specified in the marketing authorisation. Its recommendations have been supported in principle by the European Commission with a view to review of Annex 16 of the EU GMP guide to reflect the proposal.
ABPI members are reviewing both the documents and we will be commenting in due course.