Agenda. Præsentation af Xellia Risikovurdering af mikrobielle kontaminanter Mikrobiologisk database

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Mads Kristiansen
7 år siden
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1 1 QC-Mikrobiologi

2 Agenda Præsentation af Xellia Risikovurdering af mikrobielle kontaminanter Mikrobiologisk database 2

3 Xellia Manufacturing Sites Copenhagen, Denmark Amphotericin B Bacitracin and Bacitracin Zinc (sterilisation only) Colistimethate Sodium Colistin Sulfate Polymyxin B Sulfate Tobramycin Sulfate Vancomycin (HCl and Base) Vancomycin vials (0.5g, 1.0g, 5g, 10g) Colistimethate sodium vials (1 miu, 2 miu, 150 mg) FDA: 2014 ISO OHSAS Raleigh, USA Budapest, Hungary Daptomycin Gramicidin Tyrothricin Vancomycin FDA: 2014 ISO OHSAS Outstanding quality track record 3 Vancomycin Leucovorin Panhematin FDA: 2014 Taizhou, P.R. China Vancomycin Bacitracin Bacitracin Zinc FDA: 2015 ISO OHSAS 18001

4 Workforce, Copenhagen ~550 employees R&D 3% Others 17% Quality + Regulatoy Affairs 22% Supply chain 58% 4

5 Xellia Specialty pharmaceutical company focused on critical care therapies for life-threatening diseases Supplying both APIs and FDFs to approx. 500 customers in 70 countries 50+ years expertise in supplying fermented and semi-synthetic products that are challenging to manufacture State-of-the-art production facilities in the United States, Europe and Asia with global regulatory approval and an unsurpassed compliance track record Continuously expanding product pipeline and geographic reach Wholly owned by Novo A/S and well financed with growing sales. International specialty pharmaceutical company 5

6 Risikovurdering Formål: SOPen skal sikre at mikroorganismer, der findes i prøver, taget på et hvilket som helst trin i produktionen, bliver identificeret og evalueret med henblik på om mikroorganismen udgør en risiko for produktets kvalitet og ultimativt for patienten. Herved samles informationer, der skal mindske den generelle risiko for tilstedeværelse af fremmede organismer og samtidig sikres det, at alle fundne organismer evalueres omhyggeligt. Alle fund skal noteres og evalueres i skemaet (bilag 1) for til enhver tid at have et opdateret overblik over de fundne mikroorganismer i et givent produkt. 6

7 Procesflow Item nr. Produktbetegnelse Produktniveau A401 A411 A412 A415 A420 A4XX Podemateriale Forfermentering Høst Råbase Base Steril/Non-steril Fermentat Fermentat Mellemprodukt Færdigvare 7

8 Risikovurdering Indeks fund af mikroorganismer i produktionsprøver. Produkt: Produktionstrin Prøveinformation (oprindeligt fund) Mikroorganisme Risikovurdering (J/N) Risikovurdering nummer Kommentarer Prøvetype: Produktionsafd.: Lot nr.: Sample-nr.: Test-nr.: Dato: Prøvetype: Produktionsafd.: Lot nr.: Sample-nr.: Test-nr.: Dato: Prøvetype: Produktionsafd.: Lot nr.: Sample-nr.: Test-nr.: Dato: 8

9 Objectionable microorganisms Table 1. Pathogenic bacteria. Gram-negative bacteria. Table 1. Pathogenic bacteria. Gram-negative bacteria. Genus Aeromonas Brucella Campylobacter Coxiella Francisella Vibrio Species A. hydrophilia A. caviae A. sobria A. veronii All species C. jejuni C. burnetii F. tularensis V. cholerae O1 and O139 V. cholerae non-o1 and non-o139 V. parahaemolyticus V. vulnificus Enterobacteriaceae family Genus Species Aerobacter All species Citrobacter All species Cronobacter All species Enterobacter All species Escherichia E. coli Klebsiella All species Plesiomonas P. shigelloides Proteus All species Providencia All species Salmonella All species Serratia All species Shigella S. sonnei S. boydii S. flexneri S. dysenteriae Yersinia Y. enterocolitica Y. pseudotuberculosis 9

10 Objectionable microorganisms Table 2. Pathogenic bacteria. Gram-positive bacteria. Table 4. Other microorganisms. Genus Bacillus cereus group Clostridium Enterococcus Listeria Mycobacterium Staphylococcus Streptococcus Species B. cereus B. thuringiensis B. weihenstephanensis B. mycoides B. pseudomycoides B. anthracis C. botulinum C. perfringens E. faecalis E. faecium E. durans E. avium L. monocytogenes M. bovis S. aureus S. pyogenes S. bovis Genus Burkholderia cepacia complex Species B. cepacia B. multivorans B. cenocepacia B. stabilis B. vietnamiensis B. dolosa B. ambifaria B. anthina B. pyrrocinia B. ubonensis B. latens B. diffusa B. arboris B. seminalis B. metallica B. contaminans B. lata Table 3. Specified organisms. 10 Genus Candida Escherichia Pseudomonas Salmonella Staphylococcus Species C. albicans E. coli P. aeruginosa All species S. aureus

11 Risikovurdering Eksempel: Risk assessment of the presence of Microbacterium sp. in Amphotericin B Mikrobiologisk database 11

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