For  more than 11 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, Southamerica, Japan 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. 

For 6 years he was 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). He was engaged in the update of PTC 1and 2 for Aseptic Processing.

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

• 30 years years experience in the daily business of Sterile/ Aseptic Production (for Bulk Pharmaceuticals/ Finish Dosage Forms and Biopharmaceuticals) and QA/ QC Microbiology (Sterility Testing/ LAL/ MET lab QC Methods) 
• Introduced two Rapid Microbiological Testing Methods at Sandoz (Chemscan/ ScanRDI 1996 and Millipore Rapid Micro Testing 2010) 
• Involved in 25 (successful) FDA audits as SME in the front line
• Several F2F meetings at the FDA CDER or CBER, EMEA, EDQM 
• 1996 created a new Sterile Bulk Media Validation Approach
• Set Up of new Media Fills/ EM programs
• Training of clean room personnel
• Introduction of Training Videos as effective training tool for clean room operators and lab technicians
• Experience with Isolator Technology 
• Head of Sandoz GmbH “Aseptic Task Force Group” 2000- 2012
• Sandoz global “Troubleshooter” worldwide for sterility and compliance problems 
• Created 2006 the Sterile Quality Risk Assessment (refer to the PDA publication 2011), rolled successfully out within all Novartis sites worldwide
• Extensive Shop Floor activities/ experiences in the sterile production

As consultant from 2013 on:

• Man in Plant
• Audits
• Training Aseptic Operations  
• Sterile Product Compliance Risk Assessments
• Preparation and support of FDA Audits
• QA Microbiology activities in start up of new aseptic filling lines (Cleanrooms/ Utilities/ Sterility Testing)
• Workshops & Shop Floor Mentoring
• Cell Culture Plants Start-Up
• Upgrade Aseptic Processing production/ QA & QC systems
• CAPA Verifications (FDA Follow Up Activities)
• Batch Record Review and Certification