Program
 
 

Good Manufacturing Practices (GMP) for Beginners

Content & Learning Objective

While developing, producing and monitoring medications, it is necessary to meet strict quality requirements while complying with national and international guidelines and specifications.

This basic course covers current European and U.S. regulations on aspects including GMP-compliant lab work and production.

Key content

  • Regulations, directives and guidelines (e.g. the EU-GMP Guideline; Title 21, Part 211 of the Code of Federal Regulations (CFR); GAMP5)
  • GMP-compliant procedures and documentation for pharmaceutical environments (analytical labs, production)
  • GMP requirements for the various steps in producing pharmaceutical
  • Quality assurance vs. quality control in the context of GMP
  • Verification, qualification, and validation requirements acc. to Annex 15 of the GMP guideline (labs, production), e.g. GAMP5, USP <1058>, Annex 11 to EU-GMP
  • Decontamination of cleanroom zones
  • Biocides, types and GMP-compliant use
  • Critical aseptic areas (grades A and B)
  • GMP compliance in deviation management, change documentation, and OOS handling
  • CAPA (corrective and preventive action) quality tools for eliminating deviations

Target Group

Technical and scientific staff members who want to improve the knowledge of GMP with no previous experiences or who want to refresh their knowledge.

Teacher

Wolf-Dieter Wanner studied pharmacy at the University of Munich. After working in a pharmacy in Augsburg for a year, he joined Henkel KGaA in Dusseldorf, building a Germany-wide consulting service and sales team specialized in disinfectants used by manufacturing companies to meet hygiene requirements. Starting in 1990, he held presentations on particulate and microbial conditioning for cleanroom manufacturers, covering the requirements of current cleanroom standards and GMP guidelines. In 2000 he switched to ECOLAB Healthcare to head a consulting team focused on aseptic pharmaceutical filling in critical A/B grades. After that he established a unified international consulting and sales team for the aseptic cleanroom operations of Adams Healthcare Ltd. in Leeds and Shield Medicare Ltd in Farnham in the United Kingdom, while taking responsibility for their German business. Since November 2011 he has continued his consulting work on a freelance basis. He holds seminars, workshops and in-house courses on a range of subjects including GMP tools and requirements, cleanroom conditions, microbiology, decontamination measures and hygiene, also training other trainers. He also gives basic and advanced courses on cleanrooms for staff of pharmaceutical companies, hospitals (cytostatics), and various cleaning service providers to help them comply with ISO 14644 and GMP.