Inspections procedures

Work instructions for managing EudraCT alerts

Adopted Reference Number: WIN/INS/2053 Legal effective date: 13/10/2014 Summary:

Managing EudraCT alerts

Work instructions for good-manufacturing-practice validation of initial marketing-authorisation applications, line extensions and variations

Adopted Reference Number: WIN/INS/2041 Legal effective date: 29/04/2013

Work instructions for data entry in Corporate GxP for good-clinical-practice and pharmacovigilance inspections

Adopted Legal effective date: 26/03/2013

Work instructions for workflow of data entry to scientific-memory database

Adopted Legal effective date: 12/02/2013

Work instructions for how to create and revise the pharmacovigilance inspections programme

Adopted Reference Number: WIN/INSP/2042 Legal effective date: 15/01/2013

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...

Adopted Reference Number: SOP/INSP/2001 Legal effective date: 27/09/2012

Work instructions for preparation of the annual good-manufacturing-practice re-inspection programme

Adopted Reference Number: WIN/INSP/2046 Legal effective date: 27/09/2012

Standard operating procedure for co-ordination of pharmacovigilance inspections

Adopted Reference Number: SOP/INSP/2045 Legal effective date: 27/09/2012

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...

Adopted Reference Number: WIN/INSP/2025 Legal effective date: 27/09/2012

Standard operating procedure for co-ordination of good-laboratory-practice inspections

Adopted Reference Number: SOP/INSP/2049 Legal effective date: 27/09/2012

Standard operating procedure for coordination of good-manufacturing-practice and good-distribution-practice inspections

Adopted Reference Number: SOP/INSP/2048 Legal effective date: 27/09/2012

Work instructions for inspection of quality control facilities located in third countries

Adopted Reference Number: WIN/INSP/2047 Legal effective date: 12/04/2017

Work instructions for how to create reports from scientific memory database (SMD)

Adopted Reference Number: WIN/INSP/2040 Legal effective date: 18/11/2011 Summary:

All the reports obtained from the scientific memory database are saved in DREAM under Cabinets/Old EDMS Structure/Operational Units/Inspections/GCP/Scientific Memory . Reports can be created on monthly basis (i.e. when selecting applications for inspection) or as product specific reports.

Work instructions for checklist for the co-ordination of training organised by the Section for Clinical and Non-Clinical Compliance

Adopted Reference Number: WIN/INSP/2034

Standard operating procedure for scientific and administrative support to working groups and working party under the Compliance and Inspection Sector's responsibility

Adopted Reference Number: SOP/INSP/2015 Legal effective date: 20/04/2012

Standard operating procedure for co-ordination of GCP inspections

Adopted Reference Number: SOP/INSP/2020 Legal effective date: 27/09/2012