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Traded Pharma Raw Materials – Compliance and EU Market Situation: View from a Trading Company with Q7 GMP focus

Traded Pharma Raw Materials – Compliance and EU Market Situation: View from a Trading Company with Q7 GMP focus. Mr. Erol Thomas Isim, Pharma Action, Germany 3 rd EFCG Congress, Lisbon, Portugal, 29. - 30. May 2008 Strategies for Compliant Pharma Sourcing. Aim of today ’s Presentation.

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Traded Pharma Raw Materials – Compliance and EU Market Situation: View from a Trading Company with Q7 GMP focus

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  1. Traded Pharma Raw Materials – Compliance and EU Market Situation: View from a Trading Company with Q7 GMP focus Mr. Erol Thomas Isim, Pharma Action, Germany 3rd EFCG Congress, Lisbon, Portugal, 29. - 30. May 2008 Strategies for Compliant Pharma Sourcing 3rd EFCG Congress, Lisbon, Portugal, 29. - 30. May 2008

  2. Aim of today’s Presentation • This presentation is intended to provide information on how the implementation of current regulations affect the supply chain of traded APIs. • Furthermore it will provide insight views on the compliance situation through an actual example. 3rd EFCG Congress, Lisbon, Portugal, 29. - 30. May 2008

  3. Introduction (I) Implementation of EU guidelines into national law of EU member states • "Basic requirements for active substances as starting materials": EU GMP Part II (curr. ed.) of the EU guidelines to good manufacturing practice for medicinal products for human and veterinary use (directive 2004/27/EC and 2004/28/EC) • in Germany via: Arzneimittel- und Wirkstoffherstellungsverordnung/ decree for manufacturing of medicinal products and active ingredients: AMWHV (in force since 10th Nov. 06, amended on 26.03.08, amendment in force since 4th April 08) • Germany was the first state to implement the changes 3rd EFCG Congress, Lisbon, Portugal, 29. - 30. May 2008

  4. Introduction (II) Implementation of a Quality Management System including: • clean room concept for sample taking, repacking and relabeling • enterprise resource planning system (ERP) Establishment of a surveillance and information network • in no. 1 and 2 API producing third countries India & China • market intelligence, auditing, pre-shipment inspections, registrations, screening of API and intermediate factories/ suppliers 3rd EFCG Congress, Lisbon, Portugal, 29. - 30. May 2008

  5. Q7 GMP Target for Traders Traders must • know and control the GMP relevant processes of the API supply chain • increase level of trading part up to legal and industry GMP requirements in regulated markets 3rd EFCG Congress, Lisbon, Portugal, 29. - 30. May 2008

  6. Differences in Q7 GMP Implementation (I) • different interpretations of the EU directives in the different member states: • Germany implemented strict regulations (i.e. identification test, GMP certificates for transit material) • Italy imposed almost prohibitive measures (compulsory third-country GMP inspections for all APIs / factories via Italian MoH, valid from: 01.01.09) 3rd EFCG Congress, Lisbon, Portugal, 29. - 30. May 2008

  7. Differences in Q7 GMP Implementation (II) • different speed of the implementation processes into national law • different enforcement of national law by official bodies within member states 3rd EFCG Congress, Lisbon, Portugal, 29. - 30. May 2008

  8. Current GMP Compliance Situation in Europe • Costs and implementation necessities of different GMP compliant systems are prohibitive to small and medium sized trading companies. • Q7 standards are not 100% suitable for trading activities (size, human resources). 3rd EFCG Congress, Lisbon, Portugal, 29. - 30. May 2008

  9. Consequences • only a few small and medium sized trading companies have invested into a QM-System • most API trading activities do not comply with the EU GMP • GMP compliant traders lack competitiveness due to higher process costs • parallel imports: loopholes remain open and are being used • finished dosage form manufacturers accept non-GMP compliant processes and as a consequence non-GMP compliant API sourcing activities, f.e. “old registrations” 3rd EFCG Congress, Lisbon, Portugal, 29. - 30. May 2008

  10. transparency competition GMP compliance (Q7, Q8, Q9, Q10, GAMP5, REACH ...) GMP Trading: Review and Preview 3rd EFCG Congress, Lisbon, Portugal, 29. - 30. May 2008

  11. Traditional API Supply Chain 3rd EFCG Congress, Lisbon, Portugal, 29. - 30. May 2008

  12. Integrated TraderGMP Supply Chain 3rd EFCG Congress, Lisbon, Portugal, 29. - 30. May 2008

  13. Excursion Heparin: “The B-Case” (I) • “unknown impurities” led to adverse reactions and possible deaths • detection methods published on March, 6th 2008 • after starting of testing, product recalls in US and Germany, followed by further product recalls in CH, FR, DK, AUS, ... (regulated markets) 3rd EFCG Congress, Lisbon, Portugal, 29. - 30. May 2008

  14. Excursion Heparin: “The B-Case” (II) • root cause according to official reading: “oversulfated chondroitin sulfate” (OSCS) inside from China made Heparin (crude / purified Heparin) • fractioned Heparin (low molecular weight) is affected too • ongoing US-FDA investigation(s) in China • insufficient inspection routines by industry and authorities • most commonly the big players are being inspected • intra-supply-chain trade, relabeling, commingling of batches remain un-inspected 3rd EFCG Congress, Lisbon, Portugal, 29. - 30. May 2008

  15. the unkown Heparin sites unkown to authorities: approx. 1‘000 to more than 2‘000 family owned/ small businesses crude work shops, many small crude brokers many small sized and medium sized purifiers Chinese Heparin Supply Chain (numbers) crude Heparin workshops small purifiers medium purifiers big purifiers to EU authorities known Heparin sites approx. 150 - 200 family owned/ small businesses crude work shops, 2 big crude work shops, > 5 big crude Heparin traders, few medium sized purifiers and 4 big sized purifiers number of inspected crude workshops and purifiers by EU-authorities ??? 3rd EFCG Congress, Lisbon, Portugal, 29. - 30. May 2008

  16. eGMP Chinese GMP Chinese Heparin Supply Chain (compliance) crude Heparin workshops small purifiers medium purifiers big purifiers non-GMP-compliant/ no production license 3rd EFCG Congress, Lisbon, Portugal, 29. - 30. May 2008

  17. case 1: compliance case 2: non-compliance case 3: “Baxter“ case 4: linkages Chinese HeparinSupply Chain (linkages) crude Heparin workshops small purifiers medium purifiers big purifiers markets eGMP Chinese GMP non-GMP-compliant/ no production license regulated un-regulated 3rd EFCG Congress, Lisbon, Portugal, 29. - 30. May 2008

  18. intransparent transparent eGMP Chinese GMP Chinese Heparin Supply Chain (reality) crude Heparin workshops small purifiers medium purifiers big purifiers markets Chinese Traders non-GMP-compliant/ no production license regulated un-regulated 3rd EFCG Congress, Lisbon, Portugal, 29. - 30. May 2008

  19. FDA 1H-NMR Spectroscopy Source: FDA 3rd EFCG Congress, Lisbon, Portugal, 29. - 30. May 2008

  20. Heparin without Contamination 3rd EFCG Congress, Lisbon, Portugal, 29. - 30. May 2008

  21. Heparin with Low Level of Contamination 3rd EFCG Congress, Lisbon, Portugal, 29. - 30. May 2008

  22. Heparin with Medium Level of Contamination 3rd EFCG Congress, Lisbon, Portugal, 29. - 30. May 2008

  23. Heparin with High Level of Contamination 3rd EFCG Congress, Lisbon, Portugal, 29. - 30. May 2008

  24. Pharma Action‘sIntegrated API Management System Pharma Action is specialised on GMP compliant API supply chain management. Benefit from our system, which: • releases bound capacities • reduces costs and redundancies • bundles suppliers and information • creates transparency • outsources threshold • concentrates on core competence 3rd EFCG Congress, Lisbon, Portugal, 29. - 30. May 2008

  25. Thank You! TRADE ACTION-PHARMA ACTION eK Kurfuerstendamm 133 10711 Berlin - Germany phone 0049 30 - 890 44 99 -0 fax 0049 30 - 890 44 99 -99 eMail office@pharma-action.com Internet www.pharma-action.com 3rd EFCG Congress, Lisbon, Portugal, 29. - 30. May 2008

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