PUPSIT: Complying with the Main Annex 1 Changes
Objective
Reasons to attend this conference:
- You learn why PUPSIT found its way into the revised EU GMP Annex 1
- Inspectors discuss what they expect from the implementation of PUPSIT in pharmaceutical companies
- Pharmaceutical companies present their strategy for PUPSIT implementation in case studies
Background
PUPSIT is one of the most intensely and controversially discussed topics in the revised EU GMP Annex 1. But why do we have this intense discussion. Do the expectations of the regulatory authorities regarding the safety of sterile filtration differ from the practice in pharmaceutical companies? If so, why? Does PUPSIT now have to be implemented 100% in every case or where are there exceptions? If so, how must these be justified? Several case studies from pharmaceutical companies focus on the companies' specific strategies for implementing the current PUPSIT requirements.
Target Audience
The event is directed at specialists from the pharmaceutical industry as well as at engineers and planners who have to deal with sterile filtration and especially PUPSIT in their daily practice.
It particularly addresses the departments:
- Production
- Quality assurance
- Engineering / Technology
Moderator
Dr Simone Biel, Merck
Registration
Detailed Programme
Introduction of the Annex 1 PUPSIT Requirement
Dr Simone Biel, Merck
Since the first draft of the new Annex 1 was published, the pre-use post-sterilization integrity test (PUPSIT) of a sterile filter was one of the most discussed topics related to the Annex 1 revision.
- What is required?
- Why is it a debate?
- How to interpret the exceptions?
Practical Aspects of PUPSIT Implementation
Guillaume Lesage, Merck
Intricated with PUPSIT are several technical challenges related to the preparation of filtration systems:
- Dry leak testing, flushing dynamics, Integrity test selection and dilution/drying challenges.
- Filtration assembly characterization insights
- Filter integrity test limits specific to single-use assembly
Case Study Boehringer Ingelheim Pharma: PUPSIT Risk Assessment: The Impact of Equipment Design
Dr Florian Witte, Boehringer Ingelheim Pharma
- Case study Boehringer Ingelheim
- PDA risk-based approach
- Holistic risk assessment including equipment design
PUPSIT – Annex 1 - Application of Risk Management
Dr Philip Hörsch, Vetter Pharma-Fertigung
- Risk Assessment for PUPSIT and Considerations of Associated
- Risks in Established Processes
- Risks of flaw masking and filter damage
- Product and process evaluations, process constraints?
- Risk-Benefit analysis
Case Study Novartis Pharma: PUPSIT – YES or NO?
Matthias Schaar, Novartis Pharma Stein
- What does Pre-use Post sterilization integrity testing (PUPSIT) mean?
- What do the guidelines say?
- What are the challenges, benefits and disadvantages for implementation?
So, what to do?
Case Study GSK: PUPSIT - From Design to Implementation
Vincent Delferriere, GSK
- Regulatory environment around PUPSIT
- Design of Single Use Solution (from Generic to custom)
- Technical Implementation challenges
- Extractable approach
- Automation equipment
- Supply challenges
Case Study Roche Diagnostics: Pre-Use Post Sterilisation Integrity Testing (PUPSIT) in the Revised Annex 1 - Friend or Foe of the Pharmaceutical Entrepreneur?
Manuel Grund, Roche Diagnostics
- Everything was better in the past... or was it? - An overview of the regulatory changes
- PUPSIT and its scientific raison d'êtr
- The process and the product - Which aspects play a major role?
- Quality Risk Management in application
To PUPSIT or not to PUPSIT? – Science-based Considerations for a risk-based Approach
Robert Schwarz, FH Campus, Vienna
- Regulations - Is a "should" sometimes a "should" or always a "must"?
- How wide or narrow can an "e.g." be interpreted?
- "Science-based" includes data - which to use or generate here?
Podium Discussion on PUPSIT
Programme as PDF
Download the programme of the Conference PUPSIT: Complying with the Main Annex 1 Changes as PDF.