QA FORUM 11 april 2013

Transkript

1 QA FORUM 11 april 2013 Så uppfyller du de globala kvalitetskraven i ett medelstort läkemedelsföretag Kerstin Johansson, Sakkunnig

2 Who We Are An international specialty healthcare company dedicated to rare diseases. Key therapeutic areas are Inflammation and Genetic diseases, with a growing focus on Hemophilia and Neonatology. A pioneer in biotechnology with world-class capabilities in protein biochemistry and biologics manufacturing. 2

3 Our Mission Our mission is to develop and deliver innovative therapies that improve the lives of patients. Seth was diagnosed with the rare disease NOMID at the age of four. 3

4 A Legacy of Capability and Innovation 2001 Spin-off from Pharmacia Operations include expertize in protein drugs originating from KabiVitrum 2004 Prolong agreement with Wyeth (later Pfizer) to manufacture drug substance for ReFacto, a drug for hemophilia A 2005 Acquisition of Swedish biotech company Arexis 2006 Partnership with Syntonix to develop a new drug for hemophilia B Listing on NASDAQ OMX Stockholm 2007 Option utilized to cooperate with Syntonix (later Biogen Idec) to develop a new drug for hemophilia A 2008 Acquisition of 3 commercial products from Amgen 2010 Acquisition of Swedish Orphan, a pioneer in orphan drugs 4

5 A Pioneer in Rare Diseases 35+ years of biologics innovation Capabilities from gene to validated process World class GMP labs and biologics facility Experienced sales- and marketing, medical affairs and market access organization. Drug development -Pre-clinical -CMC -Clinical Regulatory Market access Manufacturing Distribution Marketing & Sales Pharmacovigilance 5

6 Compliance = GxP Internt tillverkning Kommersiell API API för kliniska studier Tillverkning hos CMO Kommersiella produkter Biotech Småmolekyler API, DS, FP Produkt för klinkiska prövningar Biotech Småmolekyler API, DS, klinisk packning EU release Distribution CMO produkter Partnerprodukter Kliniska studier Safety 6

7 Product Revenues by Region, 2011 Nordic Countries 32% North America 25% Rest of Europe 40% Headquarters Rest of World 3%

8 Flexibilitet Breda komptensområden Ett kvalitetssystem 8

9 Flexibelt, brett kvalitetssystem Gemensamma system för GMP/GDP SOP system Avvikelser CAPA Ändringsärenden VMP IT-system 9

10 Dokumentationssystem Pappersbaserade system SOPar CC Avvikelser/CAPA Valdering/Kvalificering Underhåll TIDSKRÄVANDE RESURSKRÄVANDE 10

11 Elektroniskt dokumentationssystem SOPar Bättre distributionskontroll R&U inbyggt i systemet Kontrollerade distribution av papperskopior (SOPar) Övriga dokument Kontrollerad implementation Metadata Färre QA resurser Ökat IT-stöd Processägare 11

12 Kontroll av kontraktstillverkare/analyslab/distributörer Avtal Auditering Certifiering Kontinuerlig kontakt Gemensam styrgrupp Konstruktionsansvarig Råvaror Få suppliers QUAC Temperaturkontroll Tempererade fordon Temperade packningar 12

13 Compliance och non-gxp Övrig complaince Code of conduct Hantering av information Miljö etc Hanteras även i SOP-systemet 13

14 Risk Management Vi gör riskutvärderingar i div olika system, olika omfattning, olika utformning Anledning till riskutvärdering: Avvikelser Ändringsärenden Process Utrustning Lokaler System Analys etc Ny tillverkare/distributör etc Produktförsörjning Där guideline föreskriver (ISO etc) Annan stor identifierad risk Dokumenteras i Avvikelseutredning CC QA-memo Teknisk rapport Annat dokument

15 Utdrag ur nya Risk Management Policy All Line managers and Project managers who have the designated responsibility for managing the company objectives are also responsible for reporting the risk assessment and action plans including residual risk on a quarterly basis. The manager in charge has the responsibility to maintain a risk report register which should be updated regularly. In addition to the regular reporting in the Management and Project teams the risk reports shall be sent to the Sobi Risk Manager who is responsible to compile the reports prior to the presentation and evaluation in the RMC. Reported risks are analyzed regarding potential cumulative effects and are aggregated and reviewed at the RMC meetings in order to finally be reported to the ELT and Audit Committee, and the Board on a quarterly basis. 15

16 Fällor Informella korridorsbeslut Oberoende kvalitetsorganisation (hire and fire) Information till management 16

17 Information till management - QMS QMS govering committee Ordförande - kvalitetschef Chefer för samtliga GxP dicipliner representerade The QMS Governess Committee ska: Kontinuerligt mäta GxP compliance inom och mellan de olika GxP diciplinerna. Utvärdera och implementera nya krav Utföra gap/risk analyser samt föreslå risk mitigerande aktiviteter Följa upp pågående aktiviteter Risk Management committee Hanterar alla risker inom företaget. Rapporterar till högsta ledningsgruppen och styrelsen. Risk manager, compliance manager, mangement, kvalitetschef. QMS working group Leds av kvalitetschef QA managers från resp GXP diciplin Övergripande SOPar, kvalitetsstandarder Förberedande till QMS GC 17