Annex 1 Conference - Live Online Current requirements for sterile manufacturing

Annex 1 Conference - Live Online

Course No 18550

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Dr (Ing) Jürgen Blattner, BSR
Walid El Azab, Steris
Dr Rainer Gnibl, GMP Inspector
Philip Hörsch, Vetter Pharma Fertigung
Dr Ulrich Kissel, Chair of the European Qualified Person Association
Arjan Langen, GE Healthcare
Stephan Löw, CSL
Dr Jean Denis Mallet, ECA, former Head of the French Pharmaceutical Inspection Dpt. AFSSAPS
Christina Meissner, AGES, Austria
Carsten Moschner, Dastex
Dr Daniel Müller, Local Government of Baden-Württemberg, Germany
Luigi Scaffidi, Boehringer Ingelheim
Dr Thais Vilgren, Novo Nordisk
Dr Ingrid Walther, Pharma Consulting Walther, Chair ECA Annex 1 Task Force
Sonja Wicks, Vetter Pharma Fertigung


This conference offers you a unique possibility to become acquainted with the new regulatory requirements of the revised Annex 1, the impact on aseptic manufacturing and the challenges relating to quality aspects.

Authority speakers as well as representatives from pharmaceutical industry and experts from technical suppliers will provide you information about their thinking about the new requirements. They will discuss the statements of the new Annex 1 on topics like Quality Risk Management, Process Simulation/Media Fill and Container Closure Integrity Testing, as well as the current expectations on premises, cleanroom qualification and the appropriate monitoring.

Additionally, the speaker will compare the requirements of the new Annex 1 with the expectations of other guidance documents like ISO 14644 or the relevant US Guidelines.


Annex 1 “Manufacture of Sterile Medicinal Products” was published for the first time in 1971. During the following years it was updated several times, as example to align classification table of clean rooms, to include guidance on media simulations and bioburden monitoring in 2005 and 2007 or relating to capping of vials in 2010.

At the end of 2017, the first draft of a fundamental revision was published, which was intended to focus on more structured guidance, including state-of-the-art principles such as quality risk management and the consideration of new technologies and innovative processes. The draft now contained new sections, e.g. for utilities, and extended sections on topics such as production and specific technologies or on the requirements of Aseptic Process Simulation (APS).

During the subsequent public consultation, over 6000 comments were submitted to EMA, which were then processed alongside the challenge of moving to Amsterdam. This resulted in the current document, which was published on 20 February 2020 for a second, restricted consultation. After reviewing the approximately 2,000 comments submitted, the Inspector Working Group (IWG) finalised the report at the beginning of 2022 and forwarded it to the responsible bodies of the European Commission for final approval.

Target Group

This conference is of interest to professionals from pharmaceutical and biopharmaceutical manufacturers, authorities and suppliers with responsibilities in
  • Aseptic Manufacturing, Quality Assurance, Quality Control, Auditing, Inspections
who are involved in
  • Contamination Control, Monitoring, Qualification and Validation, Self Inspection, Quality Affairs, Process Simulation/Media Fill

Technical Requirements

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Future Sterile Manufacturing – Some Thoughts about the Annex 1 Changes
QRM in Sterile Manufacturing – Industrial Experience
  • Strengths and limitations of an EM program
  • Trending: detecting changes
  • Use of modern technologies
  • Response to level excursions
Quality Risk Management - Inspector’s Experiences
  • QRM in Annex 1, more than CCS
  • Inspector‘s expectations on implementation of QRM principle
  • Best and worst case examples
Contamination Control Strategy - Inspector’s View on an Overarching Strategy
  • Requirements
  • Expectations & interpretations
The ECA CCS Guide – a Brief  Overview
  • Guide scope and purpose
  • Structure & content overview
Ready to Present your CCS
  • How to develop the strategy
  • How to have your documents available and accessible
Process Simulation – Annex 1 Requirements
  • Requirements
  • Expectations & interpretations
Aseptic Process Simulation (APS /Media Fill) –
  • Industrial Point of View
  • Different Designs / Simulation long filling times
  • Risk-based approach for interventions
Will the new Annex 1 Change Batch Certification?
  • How QPs involve in batch certification of sterile products
  • Explicit requirements
  • Sterile products, complex supply chains, and imports
Annex 1 vs. ISO 14644-1 
Requirements from a Technical Point of View
  • Accordance and differences
  • The Issue with the particle sizes
  • Qualification challenges
Cleaning and Disinfection in the Light of Annex 1
  • How QPs involve in batch certification of sterile products
  • Explicit requirements
  • Sterile products, complex supply chains, and imports
Sterile Filtration & Container Closure - Annex 1 Requirements
  • Sterile filtration requirements
  • Pre-Use-Post-Sterilization-Integrity-Testing (PUPSIT) of sterile filters
  • Container Closure Integrity Testing (CCIT)
  • Visual inspection process
CCIT and PUPSIT - New Requirements from the Draft Annex, but also Deeper Insight into Methods and Practice
  • PUPSIT: Risk Assessment for PUPSIT and Considerations of Associated Risks in Established Processes
Environmental & Process Monitoring - Inspector’s View
  • Summary of requirements from entire Annex 1
  • Essentials for inspection
Environmental Monitoring – Current Methodology and Experiences
  • Strengths and limitations of an EM program
  • Trending: detecting changes
  • Use of modern technologies
  • Response to level excursions
Barrier Systems – the Current Way
  • What makes a real barrier?
  • What are the limitations of isolators, of RABS?
  • Are Isolators less “performant” than RABS?
Isolators and Monitoring  - The Challenge of Modern Systems
Authorities‘ Point of View on RABS and Isolators
  • Requirements for barrier systems in new Annex
  • Major changes compared to previous Version (Annex 1, 2008)
  • Inspector’s comments on changed requirements
Enhanced Requirements on Facilities and Utilities
  • Facilities: airlocks and pass-boxes ; insertion of barrier technologies
  • Utilities: water, steam and gases
  • Implicit requirements
  • Lyophilisation facilities
  • Media-fill rooms
  • Equipment for barrier technologies? 
Personnel - Behaviour and Access into Cleanrooms
  • Requirements for personnel in new Annex 1
  • Developments since version 2008 of Annex 1
  • Comments of inspector on implementation
New Requirements on a Cleanroom Garment System as an Essential Element of the Contamination Control Strategy
  • The „new“ Annex 1
  • Contamination control strategy for garments
  • Risk Management
Comparison of Annex 1 with Other Relevant
  • Documents
  • Clean room grades
  • Gowning
  • Monitoring
  •  Trending

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