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 (+ 70 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.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.
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 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 TR 22 (Media Fill), and engaged in the update of PTC 1 for Aseptic Processing.
Since 2023 he is Co-Chair in the new PDA working group "PTC for RABS".
- Risk and Gap Assessments in Aseptic Processing
- EU Annex 1 Expertise
- Workshops Aseptic Processing
- Troubleshooting "Nonsterilities"
- QA/QC Microbiology Expertise
- Man in Plant / Audits
- Aseptic Processing Expertise
- Media Fill and Environmental Monitoring
- Risk Assessments (HAZOP/ FMEA)