Scientific Articles on GxP Audits

On these pages you will find news about the blue inspection body GmbH and all the latest information about the auditing of active pharmaceutical ingredient manufacturers in accordance with current GxP guidelines.

Archiv

2016

    2015

      2014

      • Audits bei Lohnherstellern 1. September 2014

        Audits bei Lohnherstellern

        Dr. Stefan Kettelhoit, blue inspection body GmbH, Münster
        und Dipl.-Ing. Jürgen Ortlepp, Infraserv Logistics GmbH, Frankfurt/Main
        erschienen in: Pharm. Ind. 76, Nr. 4, 544–550 (2014)

        Ein Hauptziel von Audits liegt darin, alle notwendigen Informationen innerhalb kurzer Zeit in der gewünschten Detailtiefe und Verlässlichkeit zu erhalten. In letzter Konsequenz muss eine Momentaufnahme ein aussagekräftiges Bild der Verhältnisse zeichnen können. Im vorliegenden Beitrag wird auf die folgenden Fragestellungen eingegangen: Welche Vorteile bietet eine risikobasierte Schwerpunktsetzung, welche Zeitpuffer und Freiheitsgrade sollte man einplanen und wie geht man am besten mit „Zeitnot im Audit“ um? Continue reading →

      • Audits & Inspections – Do’s and Don’t’s 10. May 2014

        Audits & Inspections – Do’s and Don’t’s

        Dr. Stefan Kettelhoit und Dipl.-Ing. Jürgen Ortlepp
        in: Pharm. Ind. 76, Nr. 4, 544-550 (2014)

        What is the meaning of the words Audits and Inspections?
        Audits as well as Inspections are terms, which are regularly used in the field of Good Manufacturing Practice (GMP). What exactly is the meaning of these terms and what are similarities or differences, respectively?

        Continue reading →

      2013

      • GMP-Zertifikate 17. December 2013

        GMP-Zertifikate

        Dr. Stefan Kettelhoit
        in: Pharmind 12/2013, 1978-1979
        und: GMP-Berater / LOGFILE Nr. 26/2013

        Ein EU-GMP-Zertifikat eines Wirkstoffherstellers bestätigt den GMP-Konformitätsstatus einer durch (EU-)Gesundheitsbehörden inspizierten Fertigungsstätte im Rahmen des Inspektionsumfangs (bzgl. bestimmter Stoffe und/oder Aktivitäten). Continue reading →

      • Good Manufacturing Practice (GMP) – compliance is a must! 17. November 2013

        Good Manufacturing Practice (GMP) – compliance is a must!

        Dr. Stefan Kettelhoit
        in: China Media Trade, Nov 2013, pp. 42-44

        Besides regulatory compliance (=compliance with the approved marketing authorisation (MA) to ensure contemporary requirements of safety, quality and efficacy are constantly met), GMP compliance (=compliance with applicable current GMP guidelines to ensure high quality standards concerning manufacture and control are met) is a must for pharmaceutical manufacturers. Continue reading →

      • European regulations – the falsified Medicines Directive 17. October 2013

        European regulations – the falsified Medicines Directive

        Some implications of the Falsified Medicines Directive (FMD) for Chinese Manufacturers Exporting Medicinal Products, APIs or Excipients to the European Union
        Dr. Kerstin Tabatt, blue inspection body GmbH
        In: China Medi Trade (中国医药经贸), Oct 2013, pp. 47-50

        What was the reason for issuing the FMD?

        At the beginning of the so called Falsified Medicines Directive (Directive 2011/62/EU) it is stated, that there is an “alarming increase of medicinal products detected in the European Union which are falsified in relation to their identity, history or source. Those products usually contain sub-standard or falsified ingredients, no ingredients at all or ingredients in the wrong dosage thus posing an important threat to public health.” Furthermore it reads “Past experience shows that such falsified medicinal products do not reach patients only through illegal means, but via the legal supply chain as well. Continue reading →

      • Typische GMP-Defizite bei Herstellern von chemischen Wirkstoffen 7. October 2013

        Typische GMP-Defizite bei Herstellern von chemischen Wirkstoffen

        Dr. Stefan Kettelhoit
        in: GMP-Berater / LOGFILE Nr. 41/2013

        Die Audit-Erfahrung zeigt, dass bestimmte GMP-Defizite häufiger auftreten.

        In diesem Unterkapitel werden typische GMP-Defizite gemäß der Audit-Erfahrung des Autors vorgestellt. Die nachfolgende Auflistung ist dabei nach den Kapiteln des EU-GMP-Leitfadens Teil II strukturiert (Vorgabetext kursiv) und erhebt weder Anspruch auf Vollständigkeit noch eine Wertung/Klassifizierung der einzelnen Defizite. Continue reading →

      • Achieving More Effective and Efficient GMP Auditing 17. February 2013

        Achieving More Effective and Efficient GMP Auditing

        In: Pharmaceutical Technology, Feb. 2013
        Stefan Kettelhoit, blue inspection body GmbH, Muenster
        Martin Van Trieste, Amgen Inc. & Rx-360

        Adherence to GMP in API manufacturing is crucial in determining the safety of drug products. Due to the limitations of quality-control testing and repeatedly occurring major API adulterations, the regulations for supplier qualification have been globally tightened. As a consequence, authorities demand more vigilance of the pharmaceutical supply chain. API and other starting material manufacturers are facing an ever-increasing demand for on-site audits from their pharmaceutical customers. Continue reading →

      2012

      2011

        2010

        • GMP for Active Pharmaceutical Ingredients: judging the audit quality from the audit report 18. February 2010

          GMP for Active Pharmaceutical Ingredients: judging the audit quality from the audit report

          Dr. Stefan Kettelhoit
          blue inspection body GmbH, Münster

          Manufacturing authorisation holders (MAHs) are obliged to ensure compliance with the Good Manufacturing Practices (GMP) throughout the complete process chain. Suppliers of active pharmaceutical ingredients (APIs) and other critical raw materials/excipients must be explicitly qualified through on-site audits. The resulting audit report serves as objective evidence for the competent authority that the respective audit obligation has been fulfilled by the MAH and that the GMP compliance status has been declared based upon comprehensible observations. Continue reading →

        2009

        • API Manufacturing: Complying with International GMP Regulations 18. July 2009

          API Manufacturing: Complying with International GMP Regulations

          in: PharmaAsia June-July 2009, S. 6-10.
          Dr Stefan Kettelhoit, GM, blue inspection body

          Asian Manufacturers of Active Pharmaceutical Ingredients (API) have to adhere to Good Manufacturing Practice (GMP) guidelines in order to penetrate Western markets.

          The majority of medicinal products manufactured in Europe and the US contain Active Pharmaceutical Ingredients (APIs) and excipients which have been manufactured in Asia. In recent years, these active and inactive pharmaceutical ingredients have become increasingly available globally as trading goods. This has often resulted in the non-compliance of APIs with the predefined and specified quality standards, affecting the safety and the health of patients who consume products that contain such ingredients. Continue reading →

        • Auditing / Qualification of Active Pharmaceutical Ingredient Manufacturers by Accredited Inspection Bodies 18. March 2009

          Auditing / Qualification of Active Pharmaceutical Ingredient Manufacturers by Accredited Inspection Bodies

          in: Pharm. Ind. 70, No. 12, 1459-1463 (2008)
          Dr. Wolfgang Heisig, blue inspection body GmbH, Muenster, and Dr. Uwe Amschler, Schwentinental

          Active ingredients for the production of medicinal products have to be manufactured according to the principles of good manufacturing practice (GMP). The licence holder has to verify this on site. As only few active ingredients are produced in Europe today, a considerable burden is induced by this obligation for every single enterprise. During the last months the responsible competent authorities have intensified their focus in the direction of the controls actually being carried out. Continue reading →

        Last Article

        • Audits bei Lohnherstellern 1. September 2014

          Audits bei Lohnherstellern

          Dr. Stefan Kettelhoit, blue inspection body GmbH, Münster
          und Dipl.-Ing. Jürgen Ortlepp, Infraserv Logistics GmbH, Frankfurt/Main
          erschienen in: Pharm. Ind. 76, Nr. 4, 544–550 (2014)

          Ein Hauptziel von Audits liegt darin, alle notwendigen Informationen innerhalb kurzer Zeit in der gewünschten Detailtiefe und Verlässlichkeit zu erhalten. In letzter Konsequenz muss eine Momentaufnahme ein aussagekräftiges Bild der Verhältnisse zeichnen können. Im vorliegenden Beitrag wird auf die folgenden Fragestellungen eingegangen: Welche Vorteile bietet eine risikobasierte Schwerpunktsetzung, welche Zeitpuffer und Freiheitsgrade sollte man einplanen und wie geht man am besten mit „Zeitnot im Audit“ um? Continue reading →

        Among others, blue audits at/for:

        bloomagefreda-logo
        alkaloidscorp-logo
        chemistry_umicore-logo
        cccmhpie-logo
        heraeus-logo
        evonik_industries-logo
        excipact-logo
        fjkerui-logo
        greenhealth-logo
        haosun-logo
        hennig-arzneimittel-logo
        diapharm-logo
        lomapharm-logo
        materiamedica-logo
        medice-logo
        nabriva-logo
        ratiopharm-logo
        rpglifesciences-logo
        rx-360-logo
        sunlightchem-logo
        tefeng-logo
        wdt-logo