For 13 years, microbiologist Guenther Gapp has been working as an independent consultant, supporting various clients and contractors worldwide with over 100 assignments across Europe, the USA, India, Korea, Japan, and South America. In many projects, he has served as an Aseptic Processing Expert, assisting companies in remediation efforts following Warning Letters, and contributing to audits, facility start-ups, training support, and other remediation activities.

Early in his career, Guenther developed a new sterile risk assessment tool (SPCRA) designed to identify and reduce microbial contamination and compliance risks in sterile product manufacturing — a tool that has proven highly effective when applied by qualified experts. The publication of this assessment tool earned him the 2011 PDA Journal of Pharmaceutical Science and Technology Award. Later, in April 2022, he received the James Agalloco Award for delivering the best PDA training course on aseptic processing in Europe during the previous year.

From June 2017 to June 2023, Guenther served as a member of the PDA Science Advisory Board and as Co-Chair of the PDA PTC “Isolator Technology in the Pharmaceutical Industry”, published in 2020. He also contributed to the PDA EU Annex 1 Team (recipient of the Michael S. Korczynski Award in April 2022), was one of the authors of PDA Technical Report 13 (Environmental Monitoring), and participated in the revision of TR 22: Aseptic Processing Simulation / Media Fill, which was published in Q3 2025. In addition, he was involved in the update of PDA “Points to Consider No. 1: Aseptic Processing” (revised 2023) and, since 2023, has served as Co-Lead of the new PDA working group “PTC 12 for RABS”, published in June 2025.

• 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