Collaboration in Working Groups

  • Deputy Head of the Working Group Quality Control / Pharmaceutical Analytics, German Pharmaceutical Society (2000 – 2008)
  • Member of Focus Group Analytics and Quality Assurance, International Association of Pharmaceutical Technology (APV) (since 2000)
    Expert forum (industry, authorities, university) for discussion of actual topics, developments and regulatory requirements, organisation of pharmaceutical education courses and trainings
  • Member of the EFPIA Working Group – Analytical Lifecycle Management (2008 – 2020), 2018 re-organised as EFPIA ICH Q2/Q14 Support Team
    Development and promotion of strategies for analytical Quality-by Design to facilitate continuous improvement and regulatory flexibility; proposal of the Analytical Target Profile (ATP) concept (White Paper 2010); support of EFPIA representatives in the ICH Q2/Q14 Expert Working Group
  • Member of the USP Expert Panel Validation and Verification (2011-2020)
    Development of a concept for an integrated lifecycle approach for analytical procedures including QbD principles and the ATP concept, proposal of a new USP General Information Chapter “The Analytical Procedure Lifecycle 〈1220〉”
  • Member of the Ph.Eur. Chromatographic Separation Techniques Working Party (since 2020)
    Revision of general chapters on chromatographic separation, advising the Commission on questions related to chromatographic separation techniques in monographs drafted by other groups of experts and working parties
  • Member of the USP Expert Committee Measurement and Data Quality (since 2020)
    Development of General Chapters (<31>, <1058>, <1220>, <1224-1226>) and solutions related to the use of metrology in compendial measurements, generation and treatment of valid analytical data, analytical procedures lifecycle management, validation, verification, and transfer of analytical procedures
Collaboration in Working Groups Ermer Quality Management

List of publications

  1. F.J. Alvarez, J. Ermer, G. Hübner, A. Schellenberger, R.L. Schowen: Catalytic Power of Pyruvate decarboxylase. Rate-limiting Events and microscopic rate constants from primary carbon and secondary hydrogen isotope effects. J. Am. Chem. Soc. 113 (1991) 8402 – 8409.
  2. D.W. Hutha, T. Heckenthaler, F.J. Alvarez, J. Ermer, G. Hübner, A. Schellenberger, R.L. Schowen. The catalytic Power of Pyruvate decarboxylase. A stochastic model for the molecular evolution of enzymes. Acta Chem. Scand. (1992) 778 – 788
  3. J. Ermer, G. Hübner, A. Schellenberger. Kinetic mechanism of pyruvate decarboxylase. Evidence for a specific protonation of the enzymic intermediate. FEBS Letters 299 (1992) 163 – 165
  4. J. Ermer, K. Rose, G. Hübner, A. Schellenberger: Subsite Affinities of Aspergillus niger glucoamylase II determined with p-Nitrophenylmaltooligosaccharides. Biol. Chem. Hoppe Seyler 374 (1993) 123 – 128.
  5. J. Ermer, J. Gerhardt, M. Siewert: Quality control of peptide drugs. Chiral amino acid analysis versus standard for icatibant acetate. Arch. Pharm. 328, (1995), 635 – 639
  6. J. Ermer, P.-G. Kibat: Validierung analytischer Verfahren, 1.Teil Anforderungen bei der Zulassung von Arzneimitteln. PZ Prisma, 4.Jahrgang 1997, Nr.4, 239 – 243
  7. J. Ermer, H. Möller: Impurities in new chemical entities. Reg. Affairs Journal, Sept. 1997, 722 – 729.
  8. J. Ermer: Impurity ‘inventory’ during drug development by means of LC-MS. 4th Pharm. Analysis Europe Conference, London (1998), Poster
  9. J. Ermer, P.-G. Kibat: Validierung analytischer Verfahren, 2.Teil Beispiele und Validierung während der Arzneimittelentwicklung. PZ Prisma 5 (1998) 122 – 128
  10. J. Ermer, P.-G. Kibat: A quality concept for impurities during drug development – use of the hyphenated LC-MS technique. Pharm. Sci. Technol. Today, 1 (1998) 76 – 82
  11. J. Ermer: The use of hyphenated LC-MS-Technique for characterisation of impurity profiles during drug development. J. Pharm. Biomed. Anal. 18 (1998) 707 – 714
  12. J. Ermer, H. Hamacher, W. Jahn, H. Möller, K. Olejniczak, M. Scharf, R. Uhmann: Qualitätssicherung synthetischer Peptidwirkstoffe. Empfehlungen der Deutschen Pharmazeutischen Gesellschaft. Pharm. Ind. 61 (1999) 1064 – 1072
  13. J. Ermer: MVA – eine Software zur effektiven Validierung analytischer Verfahren. Nachr. Chem. Tech. Lab., 47 (1999) Nr. 11, 1334 – 1337
  14. J. Ermer: Validierung in der pharmazeutischen Analytik. In: Handbuch der Validierung, Ed. S. Kromidas, Wiley-VCH, Weinheim 2000, 320 – 359
  15. J. Ermer, M. Vogel: Applications of hyphenated LC-MS techniques in pharmaceutical analysis. Biomedical Chromatography 14 (2000) 373 – 383
  16. J. Ermer: Validation in pharmaceutical analysis. Part I: an integrated approach. J. Pharm. Biomed. Anal. 24 (2001) 755 – 767
  17. J. Ermer, J.S. Landy Validation of analytical procedures. In: Encyclopedia of Pharmaceutical Technology, p. 507-28, Ed. J. Swarbrick, 2nd Edition, ISBN13:9780824721527, ISBN10:0824721527 (2004) Informa Healthcare
  18. H. Wätzig, J. Ermer: Positionspapier der Deutschen Pharmazeutischen Gesellschaft zum Thema Spezifikationssetzung. Pharm. i.u. Zeit 31 (2002) 501 – 503
  19. J. Ermer: Validierung analytischer Verfahren – nach der Prokrustes-Methode? LABO März 2003, 54-57
  20. J. Ermer: Analytische Verfahren rationell validieren. Nachr. Chemie 51 (2003) 697-700
  21. J. Ermer, H. Wätzig: Setting specification acceptance criteria under consideration of analytical variability. Reg. Affairs Journal (Pharma) July 2003, 1-3
  22. H. Wätzig, J. Ermer, Pharmazie in unserer Zeit, 32(3), 254-256 (2003)
  23. H. Wätzig, J. Ermer: Analytische Unsicherheit und rationale Entwicklung von Akzeptanzkriterien bei Gehaltsbestimmungen für Wirkstoffe und Fertigprodukte. 1. Mitteilung: Wirkstoffe. Pharm. Ind. 65 (2003) 1070-1074.
  24. H. Wätzig, J. Ermer: Analytische Unsicherheit und rationale Entwicklung von Akzeptanzkriterien bei Gehaltsbestimmungen für Wirkstoffe und Fertigprodukte. 2. Mitteilung: Fertigprodukte. Pharm. Ind. 65 (2003) 1184-1190.
  25. K.A. Kovar, H. Wätzig, J. Ermer: Unsicherheit über die Unsicherheit. PZ Prisma,11 (4) (2003), 257-265.
  26. J. Ermer: Analytical validation with a special focus on stability considerations. Am. Pharm. Outsourcing, 5 (1) (2004) 24-32
  27. J. Ermer: Bewertung analytischer Daten, Ausreißer und Out-of-Specificiation-Ergebnisse / Der Entwurf des USP-Kapitels <1010>. PharmInd, 8 (2004) 1019-1021
  28. J. Ermer: Validation of Cleaning Methods. World Pharmaceutical Frontiers, 2004/2005, 129-131
  29. U. Schepers, J. Ermer, L. Preu, H. Wätzig: Wide concentration range investigation of recovery, precision and error structure in HPLC. J. Chromatogr. B 810 (2004) 111-118
  30. J. Ermer, H.-J. Ploss: Validation in Pharmaceutical Analysis Part II: Central importance of precision to establish acceptance criteria and for verifying and improving the quality of analytical data. J. Pharm. Biomed. Anal. 37/5 (2005) 859-870
  31. J. Ermer, J.H.McB. Miller (Eds.) Method Validation in Pharmaceutical Analysis. A Guide to Best Practice. Wiley VCH, Weinheim 2005, ISBN: 3-527-31255-2
  32. J. Ermer, C. Arth, P. De Raeve, D. Dill, H.D. Friedel, H. Höwer-Fritzen, G. Kleinschmidt, G. Köller, H. Köppel, M. Kramer, M. Maegerlein, U. Schepers, H. Wätzig: Precision from drug stability studies. Investigation of reliable repeatability and intermediate precision of HPLC assay procedures. J. Pharm. Biomed. Anal. 38/4 (2005) 653-663
  33. J. Ermer: Neue Entwürfe für allgemeine USP-Kapitel:<1058> Qualifizierung von Analysengeräten; <1226> Verifizierung von Arzneibuchmethoden. Pharm.Ind. 67 (6) (2005) 699 – 702
  34. J. Ermer: Effiziente Validierung in der pharmazeutischen Analytik. Eine Navigationshilfe. GIT 12 (2006), 1120-22
  35. J. Ermer: 3. Allgemeine Beurteilung analytischer Daten in: Chromatographische Messdaten richtig auswerten und bewerten – Ein Praxishandbuch für die HPLC und GC (S. Kromidas und H.-J. Kuß, Eds.), Wiley VCH, Weinheim (2008) 143-167
  36. J. Ermer: 13. Anforderungen an (chromatografische) Daten in der pharmazeutischen Analytik. in: Chromatographische Messdaten richtig auswerten und bewerten – Ein Praxishandbuch für die HPLC und GC (S. Kromidas und H.-J. Kuß, Eds.), Wiley VCH, Weinheim (2008) 359-378
  37. J. Ermer, 8 . General Interpretation of Analytical Data. In: Quantification in LC and GC. A Practical Guide to Good Chromatographic Data (H.-J. Kuss and S. Kromidas, Eds.), Wiley VCH, Weinheim, 2009, 167-189
  38. J. Ermer, 16 . Requirements of (Chromatographic) Data in Pharmaceutical Analysis. In: Quantification in LC and GC. A Practical Guide to Good Chromatographic Data (H.-J. Kuss and S. Kromidas, Eds.), Wiley VCH, Weinheim, 2009, 321-339
  39. L. Kaminski, M. Degenhardt, J. Ermer, C. Feußner, H. Höwer-Fritzen, P. Link, B. Renger, M. Tegtmeier, H. Wätzig: Efficient and economic HPLC performance qualification. J. Pharm. Biomed. Anal. 51 (2010) 557-564
  40. J. Ermer, P.J. Borman, J. Carolan, P. Faulkner, C. Finkler, O. Grosche, M. Hanna-Brown, J. Hoffmann, I. Gill, A. Lenhart, P.W. Nethercote, A. Rignall, T. Sokoliess, G. Wegener und M. Pohl: „Quality by Design“ bei analytischen Verfahren. Konsequenzen und Möglichkeiten. Pharm.Ind. 72 (2) (2010) 256-264
  41. M. Schweitzer, M. Pohl, M. Hanna-Brown, P. Nethercote, P. Borman, G. Hansen, K. Smith, J. Larew, J. Carolan, J. Ermer, P. Faulkner, C. Finkler, I. Gill, O. Grosche, J. Hoffmann, A. Lenhart, A. Rignall, T. Sokoliess, and G. Wegener: Implications and Opportunities of Applying QbD Principles to Analytical Measurements. Pharmaceutical Technology, February 2010, 52-59
  42. J. Ermer: Quality by Design: A Lifecycle Concept for Pharmaceutical Analysis. European Pharmaceutical Review (2011) Issue 3, 32-39
  43. J. Ermer, G. Jilge: Kapitel 23. Validierung in der pharmazeutischen Analytik. In: Handbuch der Validierung, Hrsg. S. Kromidas, Wiley-VCH, Weinheim 2011, 429 – 468, ISBN-10: 3-527-32938-2, ISBN-13: 978-3-527-32938-0
  44. L. Kaminski, J. Ermer, C. Feußner, A. Groh, H. Höwer-Fritzen, P. Link, B. Renger, M. Tegtmeier, H. Wätzig, and R.D. McDowall: Why system suitability tests are not a substitute for analytical instrument qualification (Part 3): Performance Qualification (PQ). LC-GC Europe 24 (8) (2011) 418 – 422
  45. P. Nethercote, J. Ermer: Quality by Design for Analytical Methods: Implications for Method Validation and Transfer. Pharmaceutical Technology 36 (10) (2012) 74-79
  46. J. Ermer, M. Limberger, K. Lis, H. Wätzig: The transfer of analytical procedures. J. Pharm. Biomed. Anal. 54 (2013), 262 – 276
  47. G.P. Martin, K.L. Barnett, C. Burgess, P.D. Curry, J. Ermer, G.S. Gratzl, J.P. Hammond, J. Herrmann, E. Kovacs, D.J. LeBlond, R. LoBrutto, A.K. McCasland-Keller, P.L. McGregor, P. Nethercote, A.C. Templeton, D.P. Thomas, J. Weitzel: Lifecycle Management of Analytical Procedures: Method Development, Procedure Performance Qualification, and Procedure Performance Verification. Pharmacopeial Forum 39(5) 2013
  48. J. Ermer: Chapter 12 Analytical Procedures: Validation, in: Encyclopedia of Pharmaceutical Science and Technology, Fourth Edition, Editor(s):James Swarbrick, ISBN 9781841848198, CRC Press 2013
  49. J. Ermer, C. Agut: Precision of the reportable result. Simultaneous optimisation of number of preparations and injections for sample and referencestandard in quantitative liquid chromatography. J.Chromatogr. A, 1353 (2014) 71–77, http://dx.doi.org/10.1016/j.chroma.2014.03.043
  50. 50. Method Validation in Pharmaceutical Analysis. A Guide to Best Practice. 2nd Edition, Eds. J. Ermer and P. Nethercote, Wiley VCH, Weinheim 2015, ISBN 978-3-527-33563-3
    P. Nethercote, J. Ermer: Chapter 1: Analytical Validation within the pharmaceutical lifecycle
    J. Ermer, Chapter 5: Method Performance Characteristics
    J. Ermer, Chapter 7.1 Method performance qualification
    C. Agut, J. Ermer: Chapter 7.5: Transfer of analytical procedures
  51. J. Ermer: 14.D Validierung analytischer Verfahren, GMP-Berater; Maas & Peither AG GMP-Verlag
  52. E. Kovacs, J. Ermer, P.L. McGregor, P. Nethercote, R. LoBrutto, G.P. Martin, H. Pappa: Stimuli to the Revision Process: Analytical Control Strategy. Pharmacopoeial Forum 42(5) 2016
  53. K.L. Barnett,P.L. McGregor, G.P. Martin, J. LeBlond, J. Weitzel, J. Ermer,S. Walfish, P. Nethercote, G.S. Gratzl, E. Kovacs: Stimuli to the Revision Process: Analytical Target Profile. Structure and Application Throughout The Analytical Lifecycle Pharmacopoeial Forum 42(5) 2016
  54. G.P. Martin, K.L. Barnett, C. Burgess, P.D. Curry, J. Ermer, G.S. Gratzl, J.P. Hammond, J. Herrmann, E. Kovacs, D.J. LeBlond, R. LoBrutto, A.K. McCasland-Keller, P.L. McGregor, P. Nethercote, A.C. Templeton, D.P. Thomas, J. Weitzel, H. Pappa,: Stimuli to the Revision Process: Proposed New USP General Chapter: The Analytical Procedure Lifecycle ⟨1220⟩
  55. J. Ermer: Analytical Target Profile: Establishment of precision requirements for assay. J. Pharm. Biomed. Anal. 160 (2018) 73-79, DOI 10.1016/j.jpba.2018.07.035
  56. R.K. Burdick, J. Ermer: Precision of the reportable value—Statistical optimization of the number of replicates. J. Pharm. Biomed. Anal. 162 (2019) 149-157, https://doi.org/10.1016/j.jpba.2018.08.062
  57. A. Rignall, P. Borman, M. Hanna-Brown, O. Grosche, P. Hamilton, A. Gervais, S. Katzenbach, J. Wypych, J. Hoffmann, J. Ermer, K. McLaughlin, T. Uhlich, C. Finkler, K. Liebelt: Analytical Procedure Lifecycle Management: Current Status and Opportunities. Pharm. Tech. Europe (2018) Vol. 30, No. 12, 10 – 16, Pharm.Tech. (2018) Vol. 42, No. 12, 18 – 23, https://www.pharmtech.com/view/analytical-procedure-lifecycle-management-current-status-and-opportunities
  58. J. Ermer, D. Aguiar, A. Boden, B. Ding, D. Obeng, M. Rose, J. Vokrot: Lifecycle management in pharmaceutical analysis: How to establish an efficient and relevant continued performance monitoring program. J. Pharm. Biomed. Anal. 181 (2020) 113051, https://doi.org/10.1016/j.jpba.2019.113051