Inspections procedures
CorporateGovernance
Standard operating procedure for notifications from marketing authorisation holders on pharmacovigilance non-compliance issues
AdoptedReference Number: SOP/INS/2061Legal effective date:
English (EN) (156.78 KB - PDF)
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Work instructions for managing EudraCT alerts
AdoptedReference Number: WIN/INS/2053Legal effective date: Summary:
Managing EudraCT alerts
English (EN) (204.51 KB - PDF)
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Work instructions for good-manufacturing-practice validation of initial marketing-authorisation applications, line extensions and variations
AdoptedReference Number: WIN/INS/2041Legal effective date:
English (EN) (119.74 KB - PDF)
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Work instructions for data entry in Corporate GxP for good-clinical-practice and pharmacovigilance inspections
AdoptedLegal effective date:
English (EN) (95.39 KB - PDF)
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Work instructions for workflow of data entry to scientific-memory database
AdoptedLegal effective date:
English (EN) (152.87 KB - PDF)
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Work instructions for how to create and revise the pharmacovigilance inspections programme
AdoptedReference Number: WIN/INSP/2042Legal effective date:
English (EN) (101.82 KB - PDF)
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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...
AdoptedReference Number: SOP/INSP/2001Legal effective date:
English (EN) (104.75 KB - PDF)
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Work instructions for preparation of the annual good-manufacturing-practice re-inspection programme
AdoptedReference Number: WIN/INSP/2046Legal effective date:
English (EN) (207.86 KB - PDF)
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Standard operating procedure for co-ordination of pharmacovigilance inspections
AdoptedReference Number: SOP/INSP/2045Legal effective date:
English (EN) (133.57 KB - PDF)
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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...
AdoptedReference Number: WIN/INSP/2025Legal effective date:
English (EN) (134.91 KB - PDF)
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Standard operating procedure for co-ordination of good-laboratory-practice inspections
AdoptedReference Number: SOP/INSP/2049Legal effective date:
English (EN) (117.03 KB - PDF)
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Standard operating procedure for coordination of good-manufacturing-practice and good-distribution-practice inspections
AdoptedReference Number: SOP/INSP/2048Legal effective date:
English (EN) (131.14 KB - PDF)
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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
AdoptedReference Number: WIN/INSP/2028Legal effective date:
English (EN) (348.75 KB - PDF)
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Work instructions for inspection of quality control facilities located in third countries
AdoptedReference Number: WIN/INSP/2047Legal effective date:
English (EN) (99.73 KB - PDF)
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Work instructions for how to create reports from scientific memory database (SMD)
AdoptedReference Number: WIN/INSP/2040Legal effective date: 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.
English (EN) (519.17 KB - PDF)
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Work instructions for checklist for the co-ordination of training organised by the Section for Clinical and Non-Clinical Compliance
AdoptedReference Number: WIN/INSP/2034
English (EN) (123.86 KB - PDF)
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Standard operating procedure for sampling and testing of centrally authorised products
AdoptedReference Number: SOP/INSP/2010Legal effective date:
English (EN) (84.17 KB - PDF)
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Standard operating procedure for sampling and testing of centrally authorised products – Reports circulation and follow-up procedure
AdoptedReference Number: SOP/INSP/2011Legal effective date:
English (EN) (98.64 KB - PDF)
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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
AdoptedReference Number: SOP/INSP/2015Legal effective date:
English (EN) (92.21 KB - PDF)
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Standard operating procedure for dealing with reports of defective medicinal products
AdoptedReference Number: SOP/INSP/2018Legal effective date:
English (EN) (151.29 KB - PDF)
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Standard operating procedure for co-ordination of GCP inspections
AdoptedReference Number: SOP/INSP/2020Legal effective date:
English (EN) (145 KB - PDF)
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