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DR. GUENTHER GAPP

Consulting in Aseptic Processing/ Microbiology/ Risk Management / Audits

For  more than 10 years the microbiologist Guenther Gapp has been working as an independent consultant with different clients and contractors worldwide (approx. 100 assignments in Europe, USA, India, Korea, Japan and South America). 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.Guenther created a new sterile risk assessment tool (SPCRA) to identify and reduce the microbial contamination and compliance risk of sterile products, which works out well if the right people are doing the assessment. The publication of this risk assessment tool won him the 2011 PDA Journal of Pharmaceutical Science and Technology Award.

Further PDA Award received April 2022: James Agalloco Award" 2021 for the best PDA training (Aseptic Processing) in Europe. 

From June 2017- June 2023 he was member in the recognized PDA Science Advisory Board, and Co- Chair in the PDA Task Force “Isolator Technology in the Pharmaceutical Industry”. Furthermore he was engaged in the PDA EU Annex 1 Team (team received in April 2022 the Michael S. Korczynzki Award), and one of the authors of the PDA TR 13 (Environmental Monitoring) and ongoing revision of TR 22 (Media Fill). He was also engaged in the update of PTC 1 and 2 for Aseptic Processing document.

Since 2023 he is Co-Chair in the new PDA working group "PTC for RABS". 

SERVICES

  • Risk and Gap Assessments in Aseptic Processing
  • EU Annex 1 Expertise
  • Workshops 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 and Senior Associate at LACHMAN CONSULTANTS

COMPANIES

RECIPHARM, REIG JOFRE, MABXIENCE, FRESENIUS KABI, INSUD PHARMA, BIOCON BIOLOGICS, KRKA, UNIVERSAL PHARMA, ROCHE, POLYPID, CELONIC, FERRING, BAUSCH & STROEBEL, INNERSPACE, DM- BIO, FORMYCON, TAKEDA, SANDOZ,  and more ...