欧盟GMP检查SOP.pdf

7 Westferry Circus ● Canary Wharf ● London E14 4HB ● United Kingdom An agency of the European Union Telephone +44 (0)20 7418 8400 Facsimile +44 (0)20 7418 8416 E-mail info@ema.europa.eu Website www.ema.europa.eu © European Medicines Agency, 2012. Reproduction is authorised provided the source is acknowledged. Standard operating procedure Title: Co-ordination of GMP/GDP inspections Status: PUBLIC Document no.: SOP/INSP/2048 Lead author Approver Effective date: 27-SEP-12 Name: Esther Martinez Name: David Cockburn Review date: 27-SEP-15 Signature: On file Signature: On file Supersedes: SOP/INSP/2019 (16-MAY-07) Date: 25-SEP-12 Date: 25-SEP-12 TrackWise record no.: 3652 1. Purpose This SOP describes how GMP and GDP inspections are coordinated by the P-CI-MQC section for human and veterinary medicinal products under the centralised procedure or in the context of a referral procedure. This SOP covers: • All GMP inspections requested by the CHMP/CVMP during the evaluation phase of initial applications for marketing authorisation, line extensions, type II variations and article 58 applications. • All GMP inspections requested in accordance with the annual GMP re-inspection programme. • All for-cause GMP inspections requested in connection with: − quality defects affecting centrally authorised medicinal products; − annual sampling and testing programmes; − referral procedures. • All for-cause active substance GDP inspections. GMP inspections in the context of Plasma Master File and Vaccines Antigen Master File certification are covered in separate procedures: SOP/INSP/2009 and SOP/INSP/2012, respectively. 2. Scope This SOP applies to P-CI-MQC section only. Standard operating procedure – PUBLIC SOP/INSP/2048, 27-SEP-12 Page 2/10 3. Responsibilities It is the responsibility of the Section Head to ensure that this procedure is adhered to within his/her own section. The responsibility for the execution of a particular part of this procedure is identified in the right-hand column of section 9. 4. Changes since last revision New SOP superseding the GMP section of SOP/INSP/2019 Coordination of pre-approval GxP Inspections and widening the purpose of SOP to cover all types of GMP inspections. Addition of GDP inspections. Introduction of Corporate GxP. 5. Documents needed for this SOP The templates needed for this SOP are located on the X drive under: X:\Templates\Others\Compliance and Inspection\GMP\Inspection Coordination or in Corporate GxP: • Template 1: Email to (co)-rapporteurs on recommended GMP inspections (only on X drive). • Template 2: GMP inspection request. • Template 3: Inspection announcement letter to applicant/MAH. • Template 4: Inspection announcement letter to inspectorate. • Template 5: Email on negative validation of inspectors (only in Corporate GxP). • Template 6: Inspection report quality review and instruction for payment order generation (only on X drive). • Template 7: Inspection outcome letter to applicant/MAH. • Template 8: Inspection outcome letter to (co)-rapporteurs. The templates for the contracts with the EU NCAs are located on the X drive under: X:\Templates\Others\Compliance and Inspection\GMP\GMP inspection CONTRACT – Human/Vet: • Template 9: GMP inspection contract. 6. Related documents • EU Legislation – EudraLex. Volume 2A - Procedures for marketing authorisation. Chapter 4 - Centralised Procedure: European Commission > DG Health - inform previous inspectorate; - update Corporate GxP and - continue with step 8 (i.e. update and send out amended Administrator Standard operating procedure – PUBLIC SOP/INSP/2048, 27-SEP-12 Page 9/10 Step Action Responsibility inspection announcement letters to applicant/MAH and inspectorate). If the date of inspection changes before its proposed first day, no further action is required. However, if the date changes after the proposed first day of inspection, inform payments shared mailbox. Validation of inspection report 11. Receive preliminary outcome and prepare for appropriate actions if necessary. Administrator 12. Is final inspection report received by deadline? If yes, go to step 13. If no, go to step 12.1 Note: It is especially important for pre-approval inspections to make sure that the report is received by the agreed deadline to avoid delays in the marketing authorisation procedure. In exceptional circumstances, late reports can lead to difficulties with financial procedures. Administrator 12.1 Contact inspectors to request final inspection report and continue with step 12. Administrator 13. Is the quality of the inspection report satisfactory (i.e. in accordance with template 6? The validation of the report should be performed within 15 working days from the day of receipt. If yes, go to step 14. If no, go to step 13.1. Administrator 13.1 Inform inspectors, request amendment of the report and continue with step 13. Note: In case the quality of the report does not satisfy the validation after having requested amendment to the c。