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Excerpt from the GMP-BERATER, Chap. 12 Sterilproduktion (12.E Aseptische Herstellung), GMP-Verlag Peither AG
Raimund Brett, gempex GmbH
Published in: pharmind 10/2024
Sterilfiltration (German language)
What insights does the ZLG document “Inspection of Transport Processes” provide for practical application?
Tim Ohlrich, gempex GmbH
Published in: pharmind 05/2024
Transportvalidierung versus Transportverifizierung (German language)
Legal framework, GACP vs. GMP, status quo
Dr. Ralf Prescher, gempex GmbH
Published in: pharmind 09/2023
Medizinal-Cannabis und Pilotversuche in der Schweiz (German language)
Dr. Martin Melzer, gempex GmbH
Published in: pharmind 06/2023
Einsatz von Consultants in der Pharmaindustrie (German language)
2 chapter as part of the book publication "GMP in the Laboratory" (German language)
Chapter 14: Change Control
Chapter 16: Self Inspection
Raimund Brett, gempex GmbH
Published in: Book "GMP in the Laboratory", WILEY-VCH, 2022 (German language)
GMP im Labor, Kapitel 14 Änderungskontrolle (Change Control) und Kapitel 16 Selbstinspektion (German language)
Excerpt of "GMP-BERATER", Chapter 9.H.5 (German language)
Dr. Peter Schober, gempex GmbH
Published in: LOGFILE, 12/ 2023
Welche GxP-regulatorischen Vorgaben sind anwendbar für die Cloud-Nutzung? (German language)
How the central element of CCS (EG GMP Annex 1) can be used for knowledge-based operational decisions
Dr. Ann-Kathrin Nedele, Dr. Martin Melzer, gempex GmbH
Published in: GMP PharmaCongress 03/2023
Die Kontaminationskontrollstrategie (CCS) als Steuerungstool (German language)
Suggestions for practice - Part 4: Comparison with the regulations
Ralf Gengenbach, gempex GmbH
Published in: pharmind 11/2020 / English October 2022
Suggestions for Practice - Part 3: Here we go - the implementation
Ralf Gengenbach, gempex GmbH
Published in: pharmind 07/2020 / English October 2022
Basic Principles of an Effective and Efficient Qualification, Part 3: implementation
Suggestions for Practice - Part 2: Planning is what counts
Ralf Gengenbach, gempex GmbH
Published in: pharmind 04/2020 / English October 2022
Basis Principles of an Effective and Efficient Qualification, Part 2: Planning
Suggestions for practice - Part 1: Basic Principles
Ralf Gengenbach, gempex GmbH
Published in: pharmind 01/2020 / English October 2022
Basic Principles of an Effective and Efficient Qualification, Part 1: Basic Principles
Excerpt from the interview with Frank Studt, Managing Director gempex GmbH, and Thomas Peither, GMP-Verlag Peither AG, at the GMP:talk at the fair Lounges 2022
Frank Studt, gempex GmbH
Published in: LOGFILE 29/2022
Reaching the next GMP Level with Inspection Readiness Projects
Becoming an internationally recognized GMP expert in 20 years -- Inspection Readiness -- gempex stands for quality, reliability, trust -- Future, Strategy, Appreciation
Published in: pharmind 06/2022
20 Jahre gempex - Partner der Industrie (German language)
Practical experience, applicable strategies, tips, tools, and checklists for a successful inspection - A guide to preparing for U.S. inspections
Dr. Ralf Aubeck, gempex GmbH
Published in: pharmind 04/2022
FDA is Coming (German language)
A new seal of quality for hemp producers, distributors, and processors guarantees product quality. Preparing for successful support.
Dr. Ralf Prescher, gempex GmbH
Published in: Hanf-Magazin 01/2022
GACP für Cannabis (German language)
Regulations and guidelines / Toxicology acceptance criteria / Practical examples
Raimund Brett, gempex GmbH
Published in: pharmind 12/2021
Reinigungsvalidierung (German language)
Know How!
Ralf Gengenbach, gempex GmbH
Published in: Pharma Quality Exchange 09/2021
A structured approach as a factor for success in the production and marketing of cannabis.
Ralf Gengenbach, gempex GmbH
Published in: Hanf Magazin 09/2021
Medizinisches Cannabis nach GMP (German language)
Concept and Establishment of the „Established Conditions (EC)“ and of the „Product Lifecycle Management (PLCM)“ Document
Dr. Martin Melzer, gempex GmbH
Published in: GMP-Journal Issue 32 10/2021 and Issue 33 02/2022
Structured approach for creating or transforming a QMS
Dr. Martin Melzer, gempex GmbH
Published in: pharmind 11/2020
Aufbau normenkonformer Qualitätssicherungssysteme (German language)
Reducing costs through practical risk management and integrated qualification
Tim Ohlrich, gempex GmbH
Published in: pharmind 06/2020
Qualifizierung beim Neubau eines Logistikzentrums (German language)
The status of GMP harmonization – expert opinion
Raimund Brett, gempex GmbH
Published in: phpro 03/2020
Gleich ist nicht dasselbe (German Language)
Are you ready for this opportunity together with your suppliers?
Gert Moelgaard, Moelgaard Consulting Denmark, Ralf Gengenbach, gempex GmbH
Published in: pharmind 12/2019
Principles, risk analysis/risk assessment, regulatory requirements, and acceptance criterion PDE value
Jörg Koppenhöfer, gempex GmbH
Published in: pharmind 06/2019
Reinigungsvalidierung in der Wirkstoffherstellung (German language)
How an efficient, time-optimized qualification could work
Ralf Gengenbach, gempex GmbH
Published in: pharmind 09 and 10/2017
GMP regulations—more than just paper!
Peter Bappert, gempex GmbH
Published in: PHARMA+FOOD 09/2017
GMP in Pharma, Food und Kosmetik (German language)
Implement the HACCP concept in phases to minimize sources of danger in production – The 7 HACCP principles
Jürgen Allzeit / Christian Nemeth, gempex GmbH
Published in: LEBENSMITTEL-TECHNOLOGIE 03/ 2017
Fokus Risiko - HACCP ist ein wichtiger Beitrag zur Lebensmittelsicherheit (German language)
Model of object-oriented risk management for the practical implementation of quality risk management throughout the product life cycle of drugs and medical devices
Dipl.-Ing. Brigitte Gübitz1,3, Dipl.-Ing. Normen Schüpferling2, Prof. Dipl.-Ing. Dr. techn. Johannes Khinast3,4
1VTU Engineering GmbH, Raaba-Grambach (Austria)
2gempex GmbH, Mannheim (Germany)
3Technische Universität Graz, Graz (Austria)
4Research Center Pharmaceutical Engineering GmbH, Graz (Austria)
Published in: Pharm. Ind. 78, Nr. 5, 660-669 (2016)
Lifecycle-Risikomanagement (German language)
Supplier qualification
Tim Ohlrich, gempex GmbH
Published in: Pharm. Ind. 78, Nr. 1, 40-44 (2016)
Lieferantenqualifizierung von Transportdienstleistern (German language)
Manufacturing Conditions in China are Changing
Ralf Gengenbach, gempex GmbH
Published in: CHEManager International 3-4/2015
Variable business models for achieving Good Manufacturing Practice compliance
Thomas Raaf, gempex GmbH
Published in: CHEManager 05/ 2014
Mit den richtigen Experten zur GMP (German language)
New approaches in the pharmaceutical indsutry
Ralf Gengenbach, gempex GmbH
Published in: ReinRaumTechnik 04/2013
Medical Devices Act (MPG) – Relationship between manufacturer, medical professional, and patient – Potential for improvement in the law
Arnulf Dietl, gempex GmbH
Published in: Contamination Control Report 01/2013
Medizinprodukte: Qualitätsanforderungen zwischen Anspruch und Wirklichkeit (German language)
gempex combines its own qualification and GMP expertise with the project management expertise of Drees & Sommer
Ralf Gengenbach, gempex GmbH
Published in: CHEManager 01-02/2013
Integrierte Qualifizierung bei Pharmaprojekten (German language)
A system transition is looming in process validation
Dr. Hans-Georg Eckert / Tim Ohlrich / Normen Schüpferling, gempex GmbH
Published in: CHEManager 23-24/2012
Keine halben Sachen – Neue Anforderungen an die Prozessvalidierung (German language)
The direct path to compliance
Dr. Ralf Weber, gempex GmbH
Published in: CHEManager 13-14/2012
IT-Validierung geht auch anders (German language)
External GMP specialists save companies time and money
Ralf Gengenbach, gempex GmbH
Published in: CHEManager 11-12/2012
Kompetente Entlastung – GMP-Praxis und -Trends (German language)
Pharmaceutical warehousing – but qualified, please!
Dr. Hans-Georg Eckert / Matthias Unser, gempex GmbH, Domenica Schultz, Movianto Deutschland GmbH
Published in: Pharma+Food – Kompendium „Produzieren im Kundenauftrag“ 2010/ 2011
Stimmt das Klima? GMP-Pharmalager (German language)
Production of chemicals in China between quality and cost pressures
Ralf Gengenbach, gempex GmbH
Published in: CHEManager 19/2010
Die Quadratur des Kreises – GMP-Produktion in China (German language)
Requirements and practical experience
Peter Bappert / Kristina Schlegel, gempex GmbH
Published in: Pharmind 07/2008
Qualifizierung pharmazeutischer Wasseranlagen (German language)
Validation of cleaning procedures in the manufacture of herbal medicinal products
Dr. Hildegard Flach / Dr. Hans-Georg Eckert, gempex GmbH
Published in: PharmaTEC 04/ 2008
Saubere Sache - Reinigungsvalidierung (German language)
GMP in Pharma, Food and Cosmetics
Peter Bappert, gempex GmbH
Published in: Kompendium von PHARMA+FOOD und CHEMIE TECHNIK 2007/ 2008
Weit mehr als nur Papier – Good Manufacturing Practice (German language)
The sense and nonsense of a quality assurance measure that produces mountains of paper
Ralf Gengenbach, gempex GmbH
Published in: PHARMA+FOOD 02/2007
Weniger ist mehr – Validierung (German language)
Regulatory requirements – Important definitions – Individual steps - Qualification of new plants – Qualification of existing plants
Ralf Gengenbach, gempex GmbH
Published in: pharmind 09/2006
FDA-gerechte Qualifizierung von Anlagen in der Wirkstoffproduktion (German language)
Early planning and a risk based approach save costs in GMP implementation
Peter Bappert, gempex GmbH
Published in: CHEManager 04/2006
Risikomanagement in der Wirkstoff-Herstellung (German language)
GMP upgrade using the risk-based approach
Peter Bappert/ Ivonne Leutert, gempex GmbH
Published in: TechnoPharm Spezial 10/2005
Auf die Planung kommt es an – organisatorische und bauliche GMP-Anforderungen in der Praxis (German language)
What's behind the risk-based approach?
Ben Hoefer, gempex GmbH
Published in: SwissPharm 04/2005
Der Risk-Based Approach der FDA – alte Konzeption oder neue Philospohie? (German language)
The qualification of active ingredient plants in accordance with requirements minimizes the effort involved
Peter Bappert, gempex GmbH
Published in: CAV 07/2004
Der Weg ist das Ziel – Validierung und Qualifizierung (German language)
As much as necessary, as little as possible
Peter Bappert, gempex GmbH
Published in: MM 2003
Wie ist der Aufwand bei der Qualifizierung / Validierung auf ein noch zu rechtfertigendes Maß zu reduzieren? (German language)
Backing the right horse - Knowing who has the best proficiency in performing a task
Ralf Gengenbach, gempex GmbH
Published in: CHEManager 12/2003
Qualifizierung – Wer ist der richtige Dienstleister? (German language)
Qualification of a vitamin plant in South Korea – just in time
Ralf Gengenbach, gempex GmbH
Published in: CT 10/2003
Von Anfang an dabei – Qualifizierung beim Anlagenbau (German language)
Efficient and cost-saving cleaning validation in the active ingredient area for multi-product plants
Jörg Koppenhöfer, gempex GmbH
Published in: Process – PharmaTEC 04/2003
Sechs Schritte zum Erfolg – Reinigungs-Validierung (German language)
For reviewing GMP compliance in the life sciences industry
Platform components – Processes – Personnel
IT-Infrastruktur-Qualifizierung (German language)
An agile system for machine and software suppliers in the GMP environment for efficiency in the creation of GxP-compliant supplier documents
IT-Validierung: Qualifizierungsdokumente-Baukasten (German language)
SOP – Implementation of compliance requirements – Validation
Validierung von Excel-Spreadsheets (German language)
Reasons – Strategy – Approach – Procedure
Optimierung von Systemen, Prozessen und Konzepten (German language)
Comprehensive integrated service for qualification management and documentation
Changed requirements due to the EU MDR
Risikomanagement für Kombinationsprodukte (German language)
Determination of measurement uncertainties – when does which approach make sense?
Messunsicherheitsbetrachtungen - MSA versus GUM (German language)
An international standard for an AI management system – brief introduction and significance for the pharmaceutical and medical device industries
ISO/IEC 42001 (German language)