Inspections
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Standard operating procedure for notifications from marketing authorisation holders on pharmacovigilance non-compliance issues (PDF/156.78 KB)
Adopted
First published: 18/04/2017
Last updated: 18/04/2017
Legal effective date: 11/04/2017
SOP/INS/2061 -
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Work instructions for managing EudraCT alerts (PDF/204.51 KB)
Adopted
First published: 13/10/2014
Last updated: 13/10/2014
Legal effective date: 13/10/2014
WIN/INS/2053 -
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Standard operating procedure for coordinating pre-approval inspections in the context of plasma-master-file certification (PDF/122.84 KB)
Adopted
First published: 21/07/2004
Last updated: 30/04/2013
Legal effective date: 29/04/2013
SOP/INSP/2009 -
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Work instructions for good-manufacturing-practice validation of initial marketing-authorisation applications, line extensions and variations (PDF/119.74 KB)
Adopted
First published: 30/04/2013
Last updated: 30/04/2013
Legal effective date: 29/04/2013
WIN/INS/2041 -
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Work instructions for data entry in Corporate GxP for good-clinical-practice and pharmacovigilance inspections (PDF/95.39 KB)
Adopted
First published: 26/03/2013
Last updated: 26/03/2013
Legal effective date: 26/03/2013 -
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Work instructions for workflow of data entry to scientific-memory database (PDF/152.87 KB)
Adopted
First published: 12/02/2013
Last updated: 12/02/2013
Legal effective date: 12/02/2013 -
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Work instructions for how to create and revise the pharmacovigilance inspections programme (PDF/101.82 KB)
Adopted
First published: 15/01/2013
Last updated: 15/01/2013
Legal effective date: 15/01/2013
WIN/INSP/2042 -
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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 prod... (PDF/104.75 KB)
Adopted
First published: 28/09/2012
Last updated: 28/09/2012
Legal effective date: 27/09/2012
SOP/INSP/2001 -
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Work instructions for preparation of the annual good-manufacturing-practice re-inspection programme (PDF/207.86 KB)
Adopted
First published: 28/09/2012
Last updated: 28/09/2012
Legal effective date: 27/09/2012
WIN/INSP/2046 -
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Standard operating procedure for co-ordination of pharmacovigilance inspections (PDF/133.57 KB)
Adopted
First published: 28/09/2012
Last updated: 28/09/2012
Legal effective date: 27/09/2012
SOP/INSP/2045 -
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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 Compli... (PDF/134.91 KB)
Adopted
First published: 28/09/2012
Last updated: 28/09/2012
Legal effective date: 27/09/2012
WIN/INSP/2025 -
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Standard operating procedure for co-ordination of good-laboratory-practice inspections (PDF/117.03 KB)
Adopted
First published: 27/09/2012
Last updated: 27/09/2012
Legal effective date: 27/09/2012
SOP/INSP/2049 -
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Standard operating procedure for coordination of good-manufacturing-practice and good-distribution-practice inspections (PDF/131.14 KB)
Adopted
First published: 27/09/2012
Last updated: 27/09/2012
Legal effective date: 27/09/2012
SOP/INSP/2048 -
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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 (PDF/348.75 KB)
Adopted
First published: 23/04/2012
Last updated: 23/04/2012
Legal effective date: 20/04/2012
WIN/INSP/2028 -
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Work instructions for calculation of fees for good-manufacturing-practice and product-related inspections (PDF/87.34 KB)
Adopted
First published: 16/04/2012
Last updated: 16/04/2012
Legal effective date: 13/04/2012
WIN/INSP/2043 -
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Work instructions for inspection of quality control facilities located in third countries (PDF/99.73 KB)
Adopted
First published: 09/01/2012
Last updated: 18/04/2017
Legal effective date: 12/04/2017
WIN/INSP/2047 -
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Work instructions for how to create reports from scientific memory database (SMD) (PDF/519.17 KB)
Adopted
First published: 18/11/2011
Last updated: 18/11/2011
Legal effective date: 18/11/2011
WIN/INSP/2040 -
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Work instructions for checklist for the co-ordination of training organised by the Section for Clinical and Non-Clinical Compliance (PDF/123.86 KB)
Adopted
First published: 04/10/2011
Last updated: 04/10/2011
WIN/INSP/2034 -
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Standard operating procedure for sampling and testing of centrally authorised products (PDF/84.17 KB)
Adopted
First published: 01/10/2007
Last updated: 13/05/2011
Legal effective date: 13/05/2011
SOP/INSP/2010 -
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Standard operating procedure for sampling and testing of centrally authorised products – Reports circulation and follow-up procedure (PDF/98.64 KB)
Adopted
First published: 01/10/2007
Last updated: 13/05/2011
Legal effective date: 13/05/2011
SOP/INSP/2011 -
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Standard operating procedure for scientific and administrative support to working groups and working party under the Compliance and Inspection Sector's responsibility (PDF/92.21 KB)
Adopted
First published: 15/07/2008
Last updated: 23/04/2012
Legal effective date: 20/04/2012
SOP/INSP/2015 -
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Standard operating procedure for dealing with reports of defective medicinal products (PDF/151.29 KB)
Adopted
First published: 01/04/2007
Last updated: 08/10/2012
Legal effective date: 08/10/2012
SOP/INSP/2018 -
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Standard operating procedure for co-ordination of GCP inspections (PDF/145 KB)
Adopted
First published: 16/05/2007
Last updated: 27/09/2012
Legal effective date: 27/09/2012
SOP/INSP/2020