Autoren

Pharmaceutical technical assistant

1979-1986 Dr. Mann Pharma Berlin, development dept.
Development of sterile, liquid and semi-solid dosage forms, production on a laboratory scale, instrumental analytics.

1986-1997 Schering AG Berlin
Dept. of pharm., analyt., chem. development
Development of solid, liquid and sterile dosage forms, production on a laboratory and technical scale, production of clinical trial products, compilation of analytical testing methods

1997-2001 Schering AG Berlin
Dept. of pharm., analyt., chem. development, quality assurance
responsible for GMP optimization, SOP-systems, manufacturing documentation, preparation and execution of audits and inspections by authorities, training programmes, qualification, validation,

since 2001 Freelance consultant for quality assurance

Publications at Maas & Peither GMP Publishing:

• GMP-MANUAL
  (Author of Chapters 6.C Qualification documentation, 11.K.7 SOP "deviations" - (example), 15.B GMP-conforming documentation, 15.C Batch documentation, 15.F.5 Master-SOP for the annual product review and 17.A.7 SOP for assigning manufacturing contracts)