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DR. GUENTHER GAPP

Consulting in Aseptic Processing/ Microbiology/ Risk Management / Audits

For seven years the microbiologist Guenther Gapp has been working as an independent consultant with different clients and contractors worldwide (50 assignments in Europe, USA, India, Brazil and Korea). In many projects he has been engaged as “Aseptic Processing Expert” in remediation of companies cited with Warning Letters, and in audits, start- up of facilities, training and remediation assignments.

Since 2017 he is member in the recognized PDA Science Advisory Board and Chair in the PDA Task Force “Isolator Technology in the Pharmaceutical Industry”. Furthermore he is engaged in the PDA Task Force group commenting the upcoming EU Annex 1 revision, and one of the authors of the ongoing revisions of PDA TR 13 (Environmental Monitoring) and TR 22 (Media Fill).

SERVICES

  • Sterile Product Compliance Risk Assessment
  • Training/ Mentoring Shop Floor 
  • Workshops about Aseptic Processing 
  • Audits
  • Troubleshooting "Nonsterilities"

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WORK EXPERIENCE

  • QA/QC Microbiology Expertise
  • Man in Plant / Audits 
  • Aseptic Processing Expertise
  • Media Fill and Environmental Monitoring 
  • Risk Assessments (HAZOP/ FMEA)

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Independent Consultant of LACHMAN, PAREXEL, AXYS- NETWORK and more

COMPANIES

FERRING, BAUSCH & STROEBEL, ZYDUS, CIPLA, INTAS, INNERSPACE, GSK, CHEMOGROUP, DM- BIO, FORMYCON, BERLIN CHEMIE, HIKMA, KRKA, TAKEDA, BIOCON, SANDOZ, GLENMARK, PFIZER, FRESENIUS, SUN, Dr.REDDYS, ALLERGAN, and more ...