Inspections

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Document(s) Language Status First published Last updated Effective Date
Standard operating procedure for notifications from marketing authorisation holders on pharmacovigilance non-compliance issues (English only) adopted 2017-04-18   2017-04-11
Work instructions for managing EudraCT alerts (English only) adopted 2014-10-13   2014-10-13
Standard operating procedure for coordinating pre-approval inspections in the context of plasma-master-file certification (English only) adopted 2004-07-21 2013-04-30 2013-04-29
Work instructions for good-manufacturing-practice validation of initial marketing-authorisation applications, line extensions and variations (English only) adopted 2013-04-30   2013-04-29
Work instructions for data entry in Corporate GxP for good-clinical-practice and pharmacovigilance inspections (English only) adopted 2013-03-26   2013-03-26
Work instructions for workflow of data entry to scientific-memory database (English only) adopted 2013-02-12   2013-02-12
Work instructions for how to create and revise the pharmacovigilance inspections programme (English only) adopted 2013-01-15   2013-01-15
Standard operating procedure for coordination of site visits in the context of the certification of quality and non-clinical data submitted by small and medium-sized enterprises developing advanced-therapy medicinal products (English only) adopted 2012-09-28   2012-09-27
Work instructions for preparation of the annual good-manufacturing-practice re-inspection programme (English only) adopted 2012-09-28   2012-09-27
Standard operating procedure for co-ordination of pharmacovigilance inspections (English only) adopted 2012-09-28   2012-09-27
Work instructions for announcement of good-clinical-practice / pharmacovigilance inspection to reporting inspectorate, applicant and third-country inspectorate prepared by the Section for Clinical and Non-clinical Compliance (English only) adopted 2012-09-28   2012-09-27
Standard operating procedure for co-ordination of good-laboratory-practice inspections (English only) adopted 2012-09-27   2012-09-27
Standard operating procedure for coordination of good-manufacturing-practice and good-distribution-practice inspections (English only) adopted 2012-09-27   2012-09-27
Work instructions for sampling and testing of centrally authorised products - update of spreadsheet for the identification of the products to be tested on the basis of a risk assessment (English only) adopted 2012-04-23   2012-04-20
Work instructions for calculation of fees for good-manufacturing-practice and product-related inspections (English only) adopted 2012-04-16   2012-04-13
Work instructions for inspection of quality control facilities located in third countries (English only) adopted 2012-01-09 2017-04-18 2017-04-12
Work instructions for how to create reports from scientific memory database (SMD) (English only) adopted 2011-11-18   2011-11-18
Work instructions for checklist for the co-ordination of training organised by the Section for Clinical and Non-Clinical Compliance (English only) adopted 2011-10-04    
Standard operating procedure for sampling and testing of centrally authorised products (English only) adopted 2007-10-01 2011-05-13 2011-05-13
Standard operating procedure for sampling and testing of centrally authorised products – Reports circulation and follow-up procedure (English only) adopted 2007-10-01 2011-05-13 2011-05-13
Standard operating procedure for scientific and administrative support to working groups and working party under the Compliance and Inspection Sector's responsibility (English only) adopted 2008-07-15 2012-04-23 2012-04-20
Standard operating procedure for dealing with reports of defective medicinal products (English only) adopted 2007-04-01 2012-10-08 2012-10-08
Standard operating procedure for co-ordination of GCP inspections (English only) adopted 2007-05-16 2012-09-27 2012-09-27