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Karin Froidbise Pharmacist GMP/GDP Inspector Chief Industry Division Tel : + 32 2 254 82 60

Karin Froidbise Pharmacist GMP/GDP Inspector Chief Industry Division Tel : + 32 2 254 82 60 karin.froidbise@afmps.be. Who I am. Who performs GDP (and GMP) inspection in Belgium ?. DG PRE authorisation G. Musch. DG POST authorisation N. Binamé. DG INSPECTION J. Van der Elst.

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Karin Froidbise Pharmacist GMP/GDP Inspector Chief Industry Division Tel : + 32 2 254 82 60

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  3. Karin Froidbise Pharmacist GMP/GDP Inspector Chief Industry Division Tel : + 32 2 254 82 60 karin.froidbise@afmps.be Who I am 3

  4. Who performs GDP (and GMP) inspection in Belgium ? DGPREauthorisation G. Musch DGPOSTauthorisation N. Binamé DGINSPECTION J. Van der Elst Special Investigation Unit R. Vancauwengergh USE Control Policy Division tbd R&D Division (human) K. Bonnarens a.i. Marketing Authorisation Division Variations & Renewals tbd Marketing Authorisation Division (human) tbd Vigilance Division (pharmaco, materio, haemo, bio) T. Roisin a.i. Industry Division K. Froidbise Dispensing Division A.Bya a.i. Ph. Debuck a.i. Health Products Division F. Meulders a.i. Medicines for Veterinary Use Division F. Falize a.i. Assessors Division W. Penninckx a.i. Proper Use Division M-L. Bouffioux a.i. 4

  5. InspectionsAdministration GCP : Good Clinical Practice GMP-GDP : Good Manufacturing Practice – Good Distribution Practice PharmacoVigilance Advertising Blood Banks, Cell and Tissue Banks Distributors of Medical Devices and Class 1 manufacturers Industry division 5

  6. InspectionsAdministration Activities Delivery of authorisations/approvals (Dir med art 40 and 77) Licensing of Blood, Cell and Tissue banks Products Delivery of the export declarations and of the subcontracting declarations Delivery of the certificates for exportation : GMP/CPP DB Data input into the databank : EUDRA GMP (authorisations/certificates) Industry division 6

  7. InspectionsAdministration Approval the qualified persons the qualified persons responsible for pharmacovigilance the qualified persons responsible for information Sampling scheduling Processing of the quality RAS Unavailability of medicines Management of the strategic stocks Secretary of the Commission for Advise Industry division 7

  8. 2 senior inspectors, 11 inspectors, 4 in training The same inspectors perform GMP and GDP inspections (with some specialisations)in GDP and in GMP companies. Education : May be pharmacist, biologist, chemist, veterinarian or physician education . Today, we have 16 pharmacists and 1 biologist. DG Inspection : the GDP/GMP inspectors team 8

  9. Positive aspects: The text is much more detailled Often only a logical developpement of the old text More parallel with GMP guideline But This detailled text can be seen as a revolutionary one New activities: brokers How to solve? A harmonized application between countries  discussion between inspectors from different authorities Information to/education of the inspected. The new draft guideline versus the old one 9

  10. The following topics are selected one, this is NOT a restrictive list. QA/SOP/Documentation/Management review Responsible person Other personnel Equipment Qualification of customers /suppliers Contract operations: subcontracts and service suppliers. Returns Falsified medicinal products  through all the chapters. Transportation Attention points in a GDP inspection 10

  11. « Deviation culture » : for everybody in the company, documented, investigated and ….solved ? (1.8.v, vi / 1.10.ii …) Good documentation (ch 4) of the corrective /preventive actions Go to the end of the problem  a good, complete, justified, solution « total solution »(1.8.vi / 2.5.ix) Think risk analysis(1.12/1.13 but also 1.8.vi/1.9/1.10.ii) Registrated communication to the management (1.10 / 8.4) The senior management must take documented actions (1.11) Quality assurance is ALIVE  never ending work QA/SOP/Documentation/Management review 11

  12. Role of the RP (all the chapter 2): Personnal implication (2.1/2.4): subcontrats (2.5.viii), choice of the suppliers (2.5.vi), verification the customers (5.8), training of the team (2.5.iii), sensitization about what is a pharmaceutical product, about counterfeit/falsified products Effectiveness: job description and back up (2.5.x) Authority (in all sites if applicable)(2.1) Good communication with all the staff (2.1) Training/qualification (2.3) Issue : RP><management = pharmaceutical quality ><commercial attitudes Responsible person 12

  13. For new personnel : performant training on GDP , sensitization on pharmaceutical products (2.10) Re training  the new guideline is an opportunity !!!(2.13) Sensitization on the problem of counterfeit/falsified medicines products (6.13/2.11) Special information on hazardous products : ex.: cyto, flammable, radioactive…if applicable (2.12). Other personnel 13

  14. More acute issue if special storage conditions are required (but not only) (3.13/ 3.14/3.19) Equipment validation (also old equipment)((3.16 / 3.26 …3.29) Maintenance (link with contracts) (3.15) Back up : management of possible breakdown (3.17/3.18) Equipment : 14

  15. Not a new requirement (trade only between authorized companies, suppling of the pharmacists and veterinarians). A very important point to avoid falsified products(5.1 / 5.2 /5.8 /) Special attention for new customers/suppliers (link with counterfeit, falsified medecines)  interest of a clear and complete authorization (5.4 / 5.6 /5.7) Recheck …(5.5 / 5.9) Special attention to unusual conditions : prices, quantity, nature, unusual suppliers/customers… be attentive ) (5.10) Link with quota system (special attention on non authorised exportations) (5.10 / 5.9) Qualification of customers /suppliers 15

  16. Special emphasis on the pharmaceutical part of the contract (7.9 / 7.10) but also operationnal SOP’s and good communication up/down and down/up (7.3 / 7.8). Think about old contracts…(1.9) Complete and professional audit when an operation is outsourced (7.2, 7.4): -- ex.: transportation, custom depots (! Facilities!) Selection of a subcontractor (5.5 / 3.11) -- ex.: rodents cleaning cooling equipements (choice, maintenance, back up…) A special point : « IT solutions ». Standards of acceptance, no blind confidence.. (3.20 …3.25) Contracts / Audits /Selection of subcontractors 16

  17. !!!!!!! Many deficiencies in the field !!!!!!!!!!! Segregated areas (6.8) Authorized , trained personnel (6.6) Autorisation of the RP BEFORE return to saleable stock (2.5.vii/6.7/6.11) Documentation (6.11) FI/FO (6.12) Special attention if special storage conditions are required (6.7 / 6.10) Returns 17

  18. !!!!!! Critical point in the distribution chain !!!!!!!! Audits  basic to choice (7.1) Including all the locations and any time (7.10) Trucks but also boats or planes…(chapter 9 principle/ 9.4) Cool-packs must be validated (9.15 / 9.19 / …) Records of temperature must be provided (9.20) Be attentive of unusual transportation conditions  worst case like tropical countries (9.2/9.3/9.5) Transportation 18

  19. Better legal basis for requirements More harmonized approach by the different EU countries. An issue in the field : how to manage this new guideline with small size wholesalers ? Many more transportation hubs involved Brokers How many are they ? How to inform them? How to indentify them ? How to inspect them? Lack of information and experience Special attention on falsified products Impact of the GDP draft for an inspector 19

  20. Thank you for your attention 20

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