Pain Points with Annex 1

Quality Risk Management in Aseptic Manufacturing: Reasonable Use
Dr Ingrid Walther, Pharma Consulting Walther

Sterile Filtration – PUPSIT and Requirements beyond
Dr Frank Sielaff, Regional Authority Darmstadt

• Requirements of Annex 1
• Expectations on PUPSIT
• Expericences from inspections
  
  

Practical Application of setting up an annual Contamination Control Strategy (CCS) Assessment
Ruben van der Galiën, GE HealthCare
Dr Prachi Sawant Raschdorf, GE HealthCare

• Practical application of setting up an annual CCS assessment within a pharmaceutical sterile and/or aseptic manufacturing company
• Annually assessment of the effectiveness of a CCS
• Keeping the CCS up to date by reflecting the current state of all sources of contamination
• Room for continual improvement
  
  

"RTU + RTS Materials – GMP Requirements for the Pharmaceutical Manufacturer and Supplier Qualification”
Dr Rainer Kahlich, Local GMP Authority of Baden-Württemberg Tübingen

• Effects of the Annex 1 revision
• Expectations for supplier qualification
• Incoming goods inspection and handling at the pharmaceutical manufacturer
• Benefits of certification according to ISO 15378
  
  

Contamination Control Strategy of RTU-Packaging Systems in relation to Annex I
Horst Koller, HK Packaging Consulting
Katharina Golly, Novartis Pharma

• Product Containers & Closures
• Sterilization Validation
• Transport Simulation
• Aseptic Processing
  
  

Steam Sterilized Isolators solve indirect Product
Contact Surface Dilemma (bowls/lanes)
Dr Geert Vandenbossche, C&E Solutions BV

• The new Annex-1 revision requires sterilization of all surfaces that touch critical components
• Possible solutions:
  • Snap-on caps
  • Offline autoclaving
  • In-situ SIP of critical component contact items
    
    

Fill & Finish of various Ready-to-Use Containers from clinical late Stage until commercial Launch of Biologicals through to high-potent Products
Stylianos Sampanis, Sanofi-Aventis Deutschland GmbH
Ralf Wagner, Optima pharma

• Filling line for a maximum of flexibility and various product requirements
• Technologies for minimizing product loss and solutions for reduced change over times
• Robotic applications for various requirements in isolator environment
• Clinical late stage applications until commercial launch

Accelerating Pharmaceutical Manufacturing: A Case Study of entering Syringe and Cartridge Fill-Finish Production
Henning Austermann, Siegfried Hameln
Klaus Ullherr, Syntegon Technology

• The seamless integration of a state-of-the-art fill finish solution within an existing production environment
• Key technical features of the machine
• Packstyle flexibility, enabling rapid adaptation to changing market requirements
• No-touch-transfer system ensuring sterility and contamination control
• 100% in-process control (IPC) enhancing product quality and compliance
• Integration of in-air isolator
• Operational efficiency with peristaltic pump with single-use filling systems
• Implementation of Annex 1 requirements in practice
  
  

H₂O₂ Ingress Study Approach for Isolator Decontamination of the AT-Vials
Dr Maria Loos, Johnson and Johnson
Adrian Keller, SKAN

• Study objective: To investigate H2O2 entry into AT vials and its effects on the filled product
• Study design: Details of the experimental setup and control groups
• Results: Interesting findings and conclusions
• Implications: Possible effects on product quality and safety
  
  

Container Closure Integrity Test
Luigi Scaffidi, Boehringer Ingelheim Pharma

• Regulations / Guidelines / Recommendations
• Overview Test procedures (in development and production)
• Norm leakage
• Case Study Boehringer Ingelheim
  
  

Flexible Production for Parenterals, from Vision to Execution
Dr Friedrich Haefele, Formerly Boehringer Ingelheim

• Evolutionary and revolutionary aspects in innovative facility design for parenteral products
• Aseptic filling & closing in gloveless isolators or better closed systems
• Unit operations for aseptic filling & closing
• Unit operations of aseptic lyophilization and/or coating of biomolecules
• Unit based 100% IPC and parametric release