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Dr. Manfred Müller

additional diploma as specialist for pharmaceutical analytics
Qualified Person University Education and Vocational Training:
Study of Pharmacy at the Johann Wolfgang Goethe University, Frankfurt/Main, Germany
Graduation in Pharmacy: July 18, 1977

Post graduate studies under Prof. H. Oelschläger at the Institute of Pharmaceutical Chemistry, Johann Wolfgang Goethe University, Frankfurt/Main, Germany in instrumental analysis on the subject of "Densitometric and polarographic determination of amines via their N-pikryl derivatives and a new, computerised evaluation algorithm"

Main Subject: Pharmaceutical Chemistry
Secondary Subjects: Pharmacology
Mathematical Statistics
Overall Grade: Excellent
Doctorate awarded: October 30, 1981

Employment History

July 01, 1977 to October 31, 1981

Institute of Pharmaceutical Chemistry, Frankfurt/Main

Research assistant/supervisor in the "Pharmaceutical Chemistry II" practical course (pharmacopoeial and instrumental analytics) working under Prof. H. Hoffmann during PhD studies

November 01, 1981 to May 31,1993

Boehringer Ingelheim, Biberach, Germany
Laboratory manager then group leader, Analytical Dept./Quality Control.
Responsible for atomic absorption, infrared spectroscopy, UV-spectroscopy, titrations e.g. Karl-Fischer Titration, polarography, gas chromatography.

Responsible for the computerized systems of the department e.g.
Design, establishment, validation and maintenance of the first LIMS system in the facility.
Qualified person for packaging material.

June 01, 1993 to May 31, 1997

Pfizer R&D Laboratories, Illertissen, Germany
Head of Analytical Research, qualified person for clinical samples

January 24, 1996 to April 14, 1996
Pfizer Central Research and Development, Sandwich, UK
3 months research at Pfizer´s main European Research Facility (invitation of the director of Analytical Research and Development)

June 01, 1997 to March 31, 2000

BioChem GmbH, Karlsruhe, Germany
Technical Director, Managing Director of a major contract research laboratory
(pharmaceutical, chemical, microbiological and toxicological testing)

April 1, 2000 to October 31, 2002

Pharmaceutical Consultancy Services Neustadt/W., Germany
Managing Director

Since November 1, 2002

Founder of PharmAdvice offering GMP-services and Computerized System Validation.


1. M.Müller, Chromatographia 9 557 (1980)
"Extension of the utilizable concentration range in densitometry (Remission, Transmission and Simultaneous Measurement) via novel, empirical curve fitting"
2. M. Müller and H.Oelschläger, Fresenius Z. Analytische Chemie 307, 109 (1981)
"Standard addition for strongly non-linear calibration curves"
3. H. Oelschläger and M. Müller, Pharmazie 36, 807 (1981)
"Comparative densitometric and polarographic (DPP) determination of methamphetamine"
4. H. Oelschläger, D. Rothley and M. Müller, Arzneim.-Forsch./Drug Res. 32(I), 72 (1982)
"The antihistamine-effect of a gel for burns and wounds, containing the components tyrothrycin, fomocaine diphenhydramine and 8-hydroxyquinoline"
5. M. Müller, DAZ 127(41), 2034 (1987)
"Determination of water in erythromycin according to the Karl Fischer method"
6. M. Müller and A. Prox, Krankenhauspharmazie 12, 282 (1991)
"Structural classification of a crystalline precipitation from an infusion solution"
7. I. Lüderwald and M. Müller, Analytiker Taschenbuch 11,1993
"Instrumental analytics in industrial pharmaceutical quality control"
8. M. Müller, Kommentar zum Deutschen Arzneibuch 10th Edition, Glipizid (analytical methods)
9. W. Leis and M. Müller, Swiss Pharma 5, 43 (1998), “Use of isolators in an analytical contract laboratory, validation and experience in sterility testing of pharmaceuticals”
10. M. Müller, PharmInd. 63(12), “FDA Draft-Guidances zu 21 CFR Part 11”
11. M. Müller, PharmInd. Ind. 6, 2002, “PIC/S Entwurf: Good Practices for Computerised Systems in Regulated „GxP“ Environments; a first assessment”
12. M. Müller, update of the commentary on Glipizide (ref. 8.) for the current edition of the European Pharmacopoeia

Conferences, training courses and workshops
Speaker and moderator at numerous national and international conferences and trainings, e.g.

Computerized systems related topics
Validierung von Spread Sheets, GMP gerechte Excel Anwendung (GAMP D-A-CH Forum)
Traceability (GAMP D-A-CH Forum)
Computerized Systems Validation (PCS Seminar)
How to comply with computerized systems regulations in the US and Europe (PCS Seminar)
Excel in a GMP environment (PCS Seminar)
Access in a GMP environment (PCS Seminar)
Word in a GMP environment (PCS Seminar)
Word processing and electronic document management in a GMP environment (PCS Seminar)
Training databases in GxP environments (GAMP D-A-CH CoP)

Inspection and auditing
Auditing computerized systems
Selfinspection and auditing
Inspection of quality control laboratories

Analytical topics
Stability testing of active ingredients, medicinal products and biotechnology derived products
Development, validation and maintenance of analytical methods

General topics
Statistical methods for quality assurance in laboratories and manufacturing
Requirements for clinical studies of biopharmaceuticals
Basics of microbiology and microbiological quality assurance
Good development practices for pharmaceutical ingredients and finished products
Good storage practices
Microbiological quality assurance
Premises and equipment, mode of operation and GMP-assessment
Validation and qualification in pharmaceutical industry
Outsorcing in pharmaceutical industry

Membership in professional organizations
ISPE, Germany/Austria/Switzerland Affiliate