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  1. Book: Quality by design

    Schmitt, Siegfried

    putting theory into practice

    2011  

    Institution Parenteral Drug Association
    Author's details [edited by] Siegfried Schmitt
    MeSH term(s) Technology, Pharmaceutical/methods ; Total Quality Management/methods ; Quality Control ; Technology, Pharmaceutical/standards ; Chemistry, Pharmaceutical/standards ; Pharmaceutical Preparations/standards
    Language English
    Size xx, 338 p. :, ill. ;, 25 cm.
    Publisher PDA ; DHI Pub
    Publishing place Bethesda, MD, USA ; River Grove, IL
    Document type Book
    ISBN 9781933722481 ; 1933722487
    Database Catalogue of the US National Library of Medicine (NLM)

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  2. Book: Fachwissen Betriebs- und Antriebstechnik

    Fritsche, Hartmut / Häberle, Gregor / Häberle, Heinz O / Schmitt, Siegfried

    Fachwissen der Elektroniker/in für Betriebstechnik sowie Maschinen- und Antriebstechnik

    2015  

    Institution Verlag Europa-Lehrmittel Nourney, Vollmer GmbH & Co
    Author's details [Autoren Hartmut Fritsche ...]
    Language German
    Size 480 S, Ill., graph. Darst, 24 cm, 829 g
    Edition 7. Aufl., erw. und überarb. Aufl., 1. Dr
    Publisher Verl. Europa-Lehrmittel Nourney, Vollmer
    Publishing place Haan-Gruiten
    Document type Book
    Accompanying material 1 CD-ROM
    ISBN 3808550074 ; 9783808550076
    Database Library catalogue of the German National Library of Science and Technology (TIB), Hannover

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  3. Article ; Online: Considerations on Auditing and GxP Requirements along the Product Lifecycle.

    Rönninger, Stephan / Schmitt, Siegfried / Rangavajhula, Vijaya / Hough, Emily / Lyda, Jim

    PDA journal of pharmaceutical science and technology

    2012  Volume 66, Issue 5, Page(s) 396–402

    Abstract: The purpose of this article is to summarize the current GxP standards which need to be applied by global pharmaceutical manufacturers in order to achieve compliance with global regulatory requirements. Companies need to follow and audit against relevant ... ...

    Abstract The purpose of this article is to summarize the current GxP standards which need to be applied by global pharmaceutical manufacturers in order to achieve compliance with global regulatory requirements. Companies need to follow and audit against relevant global/regional and domestic laws as well as focusing on the lifecycle aspects of the product and processes involved from development through to routine commercial manufacture. This article was written under the auspices of PDA's Paradigm Change for Manufacturing Operations (PCMO(SM)) task force on risk-based auditing.
    Language English
    Publishing date 2012-09
    Publishing country United States
    Document type Journal Article
    ZDB-ID 1205009-x
    ISSN 1948-2124 ; 0277-3406 ; 1076-397X ; 0279-7976 ; 1079-7440
    ISSN (online) 1948-2124
    ISSN 0277-3406 ; 1076-397X ; 0279-7976 ; 1079-7440
    DOI 10.5731/pdajpst.2012.00881
    Database MEDical Literature Analysis and Retrieval System OnLINE

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    In stock of ZB MED Cologne/Königswinter

    Zs.B 766: Show issues Location:
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    Zs.MO 525: Show issues

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  4. Article ; Online: Regulatory, biosafety and safety challenges for novel cells as substrates for human vaccines.

    Hess, Ralf D / Weber, Friedemann / Watson, Keith / Schmitt, Siegfried

    Vaccine

    2012  Volume 30, Issue 17, Page(s) 2715–2727

    Abstract: In the development of novel substrates used for production of human vaccines there has been significant progress made in recent years. Emerging and re-emerging infectious diseases like the recent porcine Influenza A virus (H1N1) pandemic necessitated the ...

    Abstract In the development of novel substrates used for production of human vaccines there has been significant progress made in recent years. Emerging and re-emerging infectious diseases like the recent porcine Influenza A virus (H1N1) pandemic necessitated the availability of unprecedented amounts of vaccines. In addition, the high demand for vaccines in the industrialised countries has also been paralleled by a steep increase in demand in developing countries. The manufacturing capability for viral vaccines produced in embryonated hen eggs and conventional/classical cell substrates, such as chicken embryo fibroblasts, has now reached its capacity limit. This constraint may be overcome by utilising other recognised cell substrates such as Madin Darby Canine Kidney (MDCK) (dog origin), Chinese Hamster Ovary (CHO) (hamster cells) or Vero cells (monkey origin) or as an alternative, introduce new cell substrates of human or avian origin. Using new cell substrates may prove to be a highly replication-proficient way of producing live viral vaccines such as Influenza A viruses. Despite some advantages, cell substrates may pose a small residual risk to humans since some of them are known to be tumourigenic in immunosuppressed animals. However, this residual risk should be considered acceptable by regulators. Safety testing requirements for cell substrates used in the manufacture of vaccines is mandated by published guidance from organisations such as World Health Organization (WHO), United States Food and Drug Administration (FDA), European Medicines Agency (EMA) and International Conferences on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human use (ICH) as well as requirements laid down in compendial monographs (Ph. Eur. and USP). This paper considers the guidance contained in these regulatory documents. In addition, the safety challenges and almost arbitrary risk-based classification of cell substrates used in the production of human vaccines together with compliance to GCCP (Good Cell Culture Practice) are discussed. Even though there has been tremendous progress in the last few years, reflected mainly by revisions and updates to regulatory guidance documents, there still is still no consensus between regulators nor significant harmonisation of the guidance documents or monographs.
    MeSH term(s) Animals ; Cell Culture Techniques ; Cell Line ; Humans ; Vaccination/legislation & jurisprudence ; Vaccines/adverse effects ; Vaccines/standards
    Chemical Substances Vaccines
    Language English
    Publishing date 2012-04-05
    Publishing country Netherlands
    Document type Journal Article ; Research Support, Non-U.S. Gov't ; Review
    ZDB-ID 605674-x
    ISSN 1873-2518 ; 0264-410X
    ISSN (online) 1873-2518
    ISSN 0264-410X
    DOI 10.1016/j.vaccine.2012.02.015
    Database MEDical Literature Analysis and Retrieval System OnLINE

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    In stock of ZB MED Cologne/Königswinter

    Zs.A 1930: Show issues Location:
    Je nach Verfügbarkeit (siehe Angabe bei Bestand)
    bis Jg. 1994: Bestellungen von Artikeln über das Online-Bestellformular
    Jg. 1995 - 2021: Lesesall (1.OG)
    ab Jg. 2022: Lesesaal (EG)
    Zs.MO 458: Show issues

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  5. Book ; Thesis: Sozialarbeit & Polizei

    Schmitt, Siegfried

    Bedarfsfeststellung und Leitlinien einer Zusammenarbeit aus sozialarbeiterischer Sicht

    1997  

    Author's details vorgelegt von Siegfried Schmitt
    Keywords Sozialarbeit ; Polizei
    Language German
    Size 4 Mikrofiches, graph. Darst
    Document type Book ; Thesis
    Thesis / German Habilitation thesis Univ., Diss.--Bamberg, 1998
    Database Former special subject collection: coastal and deep sea fishing

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  6. Article: Regulatory, biosafety and safety challenges for novel cells as substrates for human vaccines

    Hess, Ralf D / Weber, Friedemann / Watson, Keith / Schmitt, Siegfried

    Vaccine. 2012 Apr. 5, v. 30, no. 17

    2012  

    Abstract: In the development of novel substrates used for production of human vaccines there has been significant progress made in recent years. Emerging and re-emerging infectious diseases like the recent porcine Influenza A virus (H1N1) pandemic necessitated the ...

    Abstract In the development of novel substrates used for production of human vaccines there has been significant progress made in recent years. Emerging and re-emerging infectious diseases like the recent porcine Influenza A virus (H1N1) pandemic necessitated the availability of unprecedented amounts of vaccines. In addition, the high demand for vaccines in the industrialised countries has also been paralleled by a steep increase in demand in developing countries. The manufacturing capability for viral vaccines produced in embryonated hen eggs and conventional/classical cell substrates, such as chicken embryo fibroblasts, has now reached its capacity limit. This constraint may be overcome by utilising other recognised cell substrates such as Madin Darby Canine Kidney (MDCK) (dog origin), Chinese Hamster Ovary (CHO) (hamster cells) or Vero cells (monkey origin) or as an alternative, introduce new cell substrates of human or avian origin. Using new cell substrates may prove to be a highly replication-proficient way of producing live viral vaccines such as Influenza A viruses. Despite some advantages, cell substrates may pose a small residual risk to humans since some of them are known to be tumourigenic in immunosuppressed animals. However, this residual risk should be considered acceptable by regulators. Safety testing requirements for cell substrates used in the manufacture of vaccines is mandated by published guidance from organisations such as World Health Organization (WHO), United States Food and Drug Administration (FDA), European Medicines Agency (EMA) and International Conferences on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human use (ICH) as well as requirements laid down in compendial monographs (Ph. Eur. and USP). This paper considers the guidance contained in these regulatory documents. In addition, the safety challenges and almost arbitrary risk-based classification of cell substrates used in the production of human vaccines together with compliance to GCCP (Good Cell Culture Practice) are discussed. Even though there has been tremendous progress in the last few years, reflected mainly by revisions and updates to regulatory guidance documents, there still is still no consensus between regulators nor significant harmonisation of the guidance documents or monographs.
    Keywords Chinese hamsters ; Food and Drug Administration ; Orthomyxoviridae ; World Health Organization ; biosafety ; cell culture ; compliance ; developed countries ; developing countries ; dogs ; eggs ; fibroblasts ; hens ; humans ; kidneys ; manufacturing ; monkeys ; pandemic ; risk ; safety testing ; swine influenza ; viral vaccines
    Language English
    Dates of publication 2012-0405
    Size p. 2715-2727.
    Publishing place Elsevier Ltd
    Document type Article
    ZDB-ID 605674-x
    ISSN 1873-2518 ; 0264-410X
    ISSN (online) 1873-2518
    ISSN 0264-410X
    DOI 10.1016/j.vaccine.2012.02.015
    Database NAL-Catalogue (AGRICOLA)

    Full text online

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    In stock of ZB MED Cologne/Königswinter

    Zs.A 1930: Show issues Location:
    Je nach Verfügbarkeit (siehe Angabe bei Bestand)
    bis Jg. 1994: Bestellungen von Artikeln über das Online-Bestellformular
    Jg. 1995 - 2021: Lesesall (1.OG)
    ab Jg. 2022: Lesesaal (EG)
    Zs.MO 458: Show issues

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  7. Book: Tabellenbuch Elektrotechnik

    Häberle, Gregor D / Häberle, Heinz O / Jöckel, Hans Walter / Krall, Rudolf / Schiemann, Bernd / Schmitt, Siegfried / Tkotz, Klaus

    Tabellen, Formeln, Normenanwendung

    (Europa-Fachbuchreihe für elektrotechnische, elektronische, mechatronische und informationstechnische Berufe)

    2013  

    Author's details bearb. von Lehrern und Ingenieuren an beruflichen Schulen und Produktionsstätten. [Autoren: Häberle, Gregor ...]
    Series title Europa-Fachbuchreihe für elektrotechnische, elektronische, mechatronische und informationstechnische Berufe
    Language German
    Size 536 S., Ill., graph. Darst, 22 cm, 712 g
    Edition 25., neu bearb. u. erw. Aufl.
    Publisher Verl. Europa-Lehrmittel Nourney, Vollmer
    Publishing place Haan-Gruiten
    Document type Book
    Accompanying material 1 CD-ROM
    ISBN 3808532270 ; 9783808530498 ; 9783808532270 ; 3808530499
    Database Library catalogue of the German National Library of Science and Technology (TIB), Hannover

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  8. Book ; Conference proceedings ; Thesis: Die Internationalen Liturgischen Studientreffen 1951 - 1960

    Schmitt, Siegfried

    zur Vorgeschichte der Liturgiekonstitution

    (Trierer theologische Studien ; 53)

    1992  

    Institution Internationales Liturgisches Studientreffen
    Catholic Church
    Katholische Kirche
    Event/congress Vatican Council (2nd, 1962-1965, BasilicadiSanPietroinVaticano) ; Internationales Liturgisches Studientreffen
    Author's details Siegfried Schmitt
    Series title Trierer theologische Studien ; 53
    Keywords Rezeption ; Liturgische Bewegung
    Language German
    Size XLII, 474 S, 24 cm
    Publisher Paulinus-Verl
    Publishing place Trier
    Document type Book ; Conference proceedings ; Thesis
    Thesis / German Habilitation thesis Univ., Diss./89--Trier, 1988
    Note Originally presented as the author's thesis, Trier, 1988-1989
    ISBN 3790212814 ; 9783790212815
    Database Former special subject collection: coastal and deep sea fishing

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  9. Book: Tabellenbuch Mechatronik

    Dahlhoff, Heinrich / Fritsche, Hartmut / Häberle, Gregor / Häberle, Heinz O / Kilgus, Roland / Krall, Rudolf / Röhrer, Werner / Schiemann, Bernd / Schmitt, Siegfried / Schultheiss, Matthias / Urian, Thomas

    Tabellen, Formeln, Normenanwendung

    2014  

    Author's details bearb. von Lehrern und Ingenieuren an beruflichen Schulen und Produktionsstätten. [Autoren: Heinrich Dahlhoff ...]
    Language German
    Size 552 S, Ill., graph. Darst, 22 cm, 734 g
    Edition 8., neu bearb. und erw. Aufl., 1. Dr
    Publisher Verl. Europa-Lehrmittel Nourney, Vollmer
    Publishing place Haan-Gruiten
    Document type Book
    ISBN 3808545089 ; 9783808545089
    Database Library catalogue of the German National Library of Science and Technology (TIB), Hannover

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  10. Book: Nathalie

    Tréverec, Gwen / Schmitt, Siegfried

    Roman

    (rororo ; 13212)

    1992  

    Title translation Nathalie <dt.>
    Author's details Gwen Tréerec. Aus dem Franz. von Siegfried Schmitt
    Series title rororo ; 13212
    Language German
    Size 125 S., 19 cm
    Edition Dt. Erstausg.
    Publisher Rowohlt
    Publishing place Reinbek bei Hamburg
    Document type Book
    ISBN 3499132125 ; 9783499132124
    Database Former special subject collection: coastal and deep sea fishing

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