Über mich / Curriculum Vitae / CV
Dr. Manfred Müller
GMP-Consultancy & Auditing, Computerized System Validation, Excel and Access Applications
pharmacist (Approbation als Apotheker)
additional diploma as specialist for pharmaceutical analytics (Fachapotheker für pharmazeutische Analytik)
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
Doctorate
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 (summa cum laude)
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, GC/MS., HPLC
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 1, 1993 to May 31, 1997 Pfizer R&D Laboratories, Illertissen, Germany
Head of Analytical Research, qualified person for clinical samples
responsible for testing and release of raw material, clinical samples, establishment of reference standards
establishment of new analytical techniques (NIR, DSC)
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 1, 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
Providing GMP-consultancy, training and seminars, interim Qulified Person
Since November 1, 2002 Founder of PharmAdvice
offering GMP- & Auditing-Services and Computerized System Validation, GxP-compliant Excel- and Access Programming.
January 1,2007 to August 31,2012 Boehringer Ingelheim, Ingelheim, Germany
in addition to working as a consultant part time employee and corporate auditor (focus on computerized system validation, GMP-auditing, product design reviews)
Current and most recent PharmAdvice projects
Data Integrity and Audit Trail Review Projects (focus on 2 major international companies project)
Software Supplier Qualification
GMP, CSV and for cause audits as lead or co-auditor
Establishing GMP-compliant computerized system management within pharmaceutical industry
Validation of computerized systems
Creation, upgrade and validation of Excel and Access applications (e.g.upgrade and validation of an Excel application to create and store GTINs (including vba/macro based forms, different user access levels, electronic signatures and an audit trail)
Creating and validating an Excel-based GMP-compliant warehouse management system for an API manufacturer (incoming goods management, supplier qualification, material requests, material movement tracking, status labels, release by QC, up to date material inventory with amount and value, audit trail and different user access levels)
Serialization
Cleaning validation
Electronic document management
Commerically available PharmAdvice Softwaretools
Validation Database to assist in establishing GMP and GAMP compliant validation
PharmAdvice Training Database to effectively manage and document employee training requirements using a role concept
Excel Validation Tool to document Excel spreadsheet and vba-code, formatting and conditional formatting, data validity checks, cell-protection, sheet and workbook protection and create functional specifications
Excel GMP-module to easily create GMP compliant Excel tables including audit trails
Publications
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 10 th Edition, Glipizid (analytical methods)
9. U.Bühler, E. Maier, M.Müller; Pharma Technologie, Trends in der pharmazeutischen Qualitätskontrolle, "Determination of water content in lyophylates by means of NIR"
10.. 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”
11.. M. Müller, PharmInd. 63(12), “FDA Draft-Guidances zu 21 CFR Part 11”
12. M. Müller, PharmInd. Ind. 6, 2002, “PIC/S Entwurf: Good Practices for Computerised Systems in Regulated „GxP“ Environments; a first assessment”
13. B.Grudzus-Zager und M.Müller, Pharm.Ind. 80(1),128 (2018)
Serialisierung in der Praxis (practical serialization)
14. CoAuthor of guideline VDI/VDE 3516, part 5, Validation in the GxP area, types of raw data, in final Revision
Conferences, training courses and workshops
Speaker and moderator at numerous national and international conferences and trainings, e.g.
Computerized systems related topics
Data integrity with focus on Excel Databases (GMP-experts seminar)
Validierung von Spread Sheets, GMP gerechte Excel Anwendung (GAMP D-A-CH Forum)
Use of a validation database for efficiently establishing System Life Cycle documentation (GAMP D-A-CH CoP)
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 laboratoriesAnalytical 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
Investigations
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
GAMP D-A-CH
GAMP D-A-CH working group raw data (VDI/VDE publication)
GAMP D-A-CH working group audit trail review