Standard operating procedure for notifications from marketing authorisation holders on pharmacovigilance non-compliance issues
English (EN) (156.78 KB - PDF)
Work instructions for managing EudraCT alerts
Managing EudraCT alerts
English (EN) (204.51 KB - PDF)
Standard operating procedure for coordinating pre-approval inspections in the context of plasma-master-file certification
English (EN) (122.84 KB - PDF)
Work instructions for good-manufacturing-practice validation of initial marketing-authorisation applications, line extensions and variations
English (EN) (119.74 KB - PDF)
Work instructions for data entry in Corporate GxP for good-clinical-practice and pharmacovigilance inspections
English (EN) (95.39 KB - PDF)
Work instructions for workflow of data entry to scientific-memory database
English (EN) (152.87 KB - PDF)
Work instructions for how to create and revise the pharmacovigilance inspections programme
English (EN) (101.82 KB - PDF)
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...
English (EN) (104.75 KB - PDF)
Work instructions for preparation of the annual good-manufacturing-practice re-inspection programme
English (EN) (207.86 KB - PDF)
Standard operating procedure for co-ordination of pharmacovigilance inspections
English (EN) (133.57 KB - PDF)
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...
English (EN) (134.91 KB - PDF)
Standard operating procedure for co-ordination of good-laboratory-practice inspections
English (EN) (117.03 KB - PDF)
Standard operating procedure for coordination of good-manufacturing-practice and good-distribution-practice inspections
English (EN) (131.14 KB - PDF)
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 (EN) (348.75 KB - PDF)
Work instructions for calculation of fees for good-manufacturing-practice and product-related inspections
Electronic records of the fees calculated in accordance with this WIN are entered in the Corporate GXP database (Letters to Inspectorates generated by the database are the core records).
English (EN) (87.34 KB - PDF)
Work instructions for inspection of quality control facilities located in third countries
English (EN) (99.73 KB - PDF)
Work instructions for how to create reports from scientific memory database (SMD)
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)
Work instructions for checklist for the co-ordination of training organised by the Section for Clinical and Non-Clinical Compliance
English (EN) (123.86 KB - PDF)
Standard operating procedure for sampling and testing of centrally authorised products
English (EN) (84.17 KB - PDF)
Standard operating procedure for sampling and testing of centrally authorised products – Reports circulation and follow-up procedure
English (EN) (98.64 KB - PDF)
Standard operating procedure for scientific and administrative support to working groups and working party under the Compliance and Inspection Sector's responsibility
English (EN) (92.21 KB - PDF)
Standard operating procedure for dealing with reports of defective medicinal products
English (EN) (151.29 KB - PDF)
Standard operating procedure for co-ordination of GCP inspections
English (EN) (145 KB - PDF)