Annex 1 - Final Version and its Impact - Live Online Conference Current requirements on aseptic manufacturing

Annex 1 - Final Version and its Impact - Live Online Conference

Course No 20687

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Walid El Azab, Steris
Dr Simone Biel, Merck
Roberto Conocchia, European Medicine Agency (EMA)
Parsa Famili, Novatek International
Dr Rainer Gnibl, GMP Inspector
Dr Philip Hörsch, Vetter Pharma Fertigung
Werner Hofstetter, Octapharma
Dr Anne-Grit Klees, Merck
Roland Koch, Gasporox
Arjan Langen, GE Healthcare
Stephan Löw, CSL
Dr Jean Denis Mallet, ECA, former Head of the French Pharmaceutical Inspection Dpt. AFSSAPS
Christina Meissner, GMP Inspector, AGES
Juliana Nassette, Ecolab
Dr Johannes Rauschnabel, Syntegon Technology
Dr Bettina Rietz-Wolf, GMP Inspector
Luigi Scaffidi, Boehringer Ingelheim
Dr Ingrid Walther, Pharma Consulting Walther, Chair ECA Annex 1 Task Force
Jörg Zimmermann, Vetter


This conference offers you a unique possibility to become acquainted with the new regulatory requirements of the revised  final 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 Fills well as the challenging topics of PUPSIT and the use of Single Use Materials.

The widely discussed topic of Contamination Control Strategy will also be discussed and the updated ECA Guide will be presented in support.

Subsequently, classical topics of contamination control like environmental monitoring and cleaning and disinfection are considered in the light of Annex 1.


The 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.

The long-awaited revised Annex 1 on the manufacture of sterile medicinal products was finally published by the European Commission on August 25, 2022 (1). The main reason for the update was to reflect changes in the regulatory environment and manufacturing, which includes a significant shift towards the application of quality risk management principles. The new Annex 1 will enter into force on August 25, 2023.

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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Introduction – Revision, Consultaion and the Annex 1 Task Force of RCA/EQPA
The Drivers for Updating the Annex 1 and the Major Changes Introduced
  • Introduction of Annex 1
  • Overview of drafting process
  • Major changes introduced
Contamination Control Strategy - Inspector´s View on an Overarching Strategy
  • Requirements
  • Expectations & Interpretations
ECA CCS Guideline: Example in Documenting the CCS and Future Challenges to Evaluate CCS Performance
  • Present the ECA guideline and Approach
  • Share example of elements to add in a CCS document using ECA template
  • Key information to have in a CCS
  • Future challenge: use of statistic and novel software to achieve holistic assessment approach
Structure and Design – Practical Aspects for a 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
Sterile Filtration – Pre-Requisites, must Haves, and Exceptions
  • The revised Annex 1 describes requirements when validating and utilizing a membrane filter to sterilize a medicinal product. There are still open questions such as
  • Redundant filtration – the extra piece of mind?
  • PUPSIT required – but exceptions allowed?
  • Filter inside or outside the isolator?
PUPSIT – Annex 1 - Application of Risk Management
  • PUPSIT: Risk Assessment for PUPSIT and Considerations of Associated Risks in Established Processes
  • Risks of flaw masking and filter damage
  • Product and process evaluations
  • Risk - Benefit analysis
CCIT – In the Light of the New Annex 1
  • Requirements for CCIT in finishing of sterile products
  • Overview of CCIT Methods
  • Applicability of the different technologies for the final containers
EudraLex Annex 1 Vol. 4 (August 2022)  - Impact for Cleaning and Disinfection
  • Regulations relating to cleaning, disinfection
  • Impact to disinfectant selection and regime design
  • Challenges of disinfectant residue management
Qualification of a Disinfection System Complying Annex 1  - Industrial Experiences
  • Case study for qualification of disinfectants
  • Efficacy – how to control?
Annex 1’s “Specific Risks Associated with Single-Use Systems”
  • Challenges when using Single-Use Systems (SUS) in sterile manufacturing
  • Annex 1’s expectations, such as supplier qualification, extractables evaluation, verification of integrity throughout the process, incoming control, operator training
  • SUS and closed systems
Quality Risk Management in the Manufacture of Sterile Medicinal Products – Inspector’s Experiences
  • QRM in the Annex 1, more than CCS
  • Inspectors expectations on implementation of QRM principle
  • Best and worst case examples
Quality Risk Management in Sterile Manufacturing
  • Dos and don’ts
  • Practical examples
  • Key steps in executing a risk assessment
Enhanced Requirements on Facilities and Utilities
  • Utilities: water, steam and gases
  • Facilities: airlocks and pass-boxes ; insertion of barrier technologies
  • Implicit requirements
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 Annex 1 – Technical and Practical Challenges

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
Environmental & Process Monitoring - Inspector´s View
  • Summary of Requirements from entire Annex 1
  • Essentials for Inspection
Optimizing your EM Program as per Revised Annex 1
  • Traditional vs Rapid Methods
  • EM risk assessment
  • Recovery studies
  • Data integrity
Annex 1 in The Age of Digitization: Re-imagining Contamination
  • TCCS and its parts – from MSC up to Monitoring
  • The benefits o a risk-based system- from DI up to trending
  • Takeaway Tools
    • Digitization in quality management and contamination control
    • Remote and hybrid work
    • Integrated Metrics
    • Process flow metrics and KBIs
Comparison of Annex 1 with Other Relevant
  • Documents
  • Clean Room Grades
  • Gowning
  • Monitoring
  • Trending
Annex 1: Industry Assessment after the two Rounds of Consultation
  • Short discussion of selected paragraphs
  • What could be achieved in the consultation?
  • What to look out for in future inspections?
  • What stumbling blocks have remained?

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