Annex 1 Conference - Current Requirements on Aseptic Manufacturing

Annex 1 Conference - Current Requirements on Aseptic Manufacturing

Berlin, Germany

Course No 16376


This conference already took place. To get a list with courses and conferences in a specific subject area according to your professional demands, please visit GMP Training Courses and Conferences by topic.

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Julia Allgaier, Vetter Pharma-Fertigung, Germany
Jürgen Blattner, BSR, Germany
David Brückner, F. Hoffmann-La Roche, Switzerland
Friedrich Haefele, Boehringer Ingelheim, Germany
Andrew Hopkins, MHRA, United Kingdom
Arjan Langen, MSD, The Netherlands
Stephan Löw, CSL, Germany
Dr Jean Denis Mallet, ECA & Former Head of the French Pharmaceutical Inspection Dpt. AFSSAPS
Christina Meissner, AGES, Austria
Daniel Müller, GMP Inspector Federal State of Baden Württemberg, Germany
Franziska Petershagen, Vetter Pharma Fertigung, Germany
Tilmann Rock, Roche, Germany
Matthias Schaar, Novartis, Switzerland
Beate Reutter, GMP Inspectorate Federal State of Schleswig-Holstein, Germany


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

Authority speakers from different European Member States as well as representatives from pharmaceutical industry will provide you with information on their thinking about the new requirements. They will discuss the statements in the new Annex 1 with regard to 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 speakers will compare the requirements of the new Annex 1 with the expectations of other guidance documents like ISO 14644 or the relevant US guidelines.
Every topic will be covered by an authority and an industry representative to compare the regulatory with the manufacturers understanding.


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, for example, to align the 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.
But for the first time, the currently published document represents a complete revision with the focus on providing a more structured guidance, including state of the art principles like Quality Risk Management and by paying attention to new technologies and innovative processes. It now includes new sections, as, for example, for utilities and enlarged topics like production and specific technologies or an increased guidance on the requirements of Aseptic Process Simulation (APS).

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


Future sterile Manufacturing – an Authority Perspective

  • Current challenges
  • Regulatory developments
  • Expectations
Quality Risk Management (QRM)
  • Inspector's expectations on implementing QRM throughout sterile manufacturing
  • Premises and equipment- principles of hygienic design
  • Process control strategies for personnel, hygiene, and environment
QRM in sterile Manufacturing - Annex 1 and recent Experiences
  • Risk assessments and the current draft revision of Annex 1
  • When and how to apply?
  • Quantitative risk modelling for aseptic manufacturing
Annex 1 – Authorities Expectation on Barrier Systems and Isolators
  • Most important changes for biopharmaceutical manufacturing - section “barrier systems”
  • Regulatory comparison of Annex 1 version 2008 and new Draft
  • GMP inspector’s comments on new/intended requirements for barriers & isolators
Industrial View: Impact on sterile Manufacturing of Biopharmaceuticals relating to Barrier Systems and Isolators
  • Possible impact on biopharmaceutical manufacturing
  • Industrial point of view – current experiences
Authority Thinking on Qualification of sterile Facilities & Utilities - General Planning, Execution, Formalities
  • The part “Utilities” in the Annex 1 Draft
  • What is new?
  • Challenges from an inspector’s point of view
The New Utilities Chapter – Industrial Experiences
  • Changes for water, gases, steam and cooling systems
  • New “Utilities” chapter in context to Annex 15
Qualification in Sterile Manufacturing: Annex 1 and ISO 14644 – a Comparison
  • Accordance and differences
  • The issue with the particle sizes
  • Qualification challenges
Container Closure Integrity – State of the Art Testing in Context of Annex 1

FDA Guidance “Sterile Drug Products Produced by Aseptic Processing vs. the new Annex1 – Accordance and Differences
  • Very brief history of the two guidances
  • The supportive tools : USP & EP
  • Main accordances
  • Some differences
  • Comparison of glossaries
  • A compared mapping of the guidances
Authorities Expectation on Contamination Control and Monitoring
  • Requirements of the revised Annex 1 Draft
  • Possible challenges and impacts
Consequences on Microbiological Contamination Control and Environmental Monitoring expected by industry
  • General concerns within contamination control
  • Contamination control strategy
  • Consequences for environmental monitoring Program
Aseptic Process Simulations - Media Fill – current Challenges
  • Current requirements and future expectations
  • Impact from a regulatory view
Media Fill, just do it? – Practical Implementation
  • Regulatory Changes regarding APS
  • Impact of the current Mediafill Programme for a Multipurpose Manufacturing Line at Vetter
Automated Media Fill Inspection – State of the Art Testing and Modern Methods in Context of Annex 1
  • State of the Art
  • How to innovate media fill inspection
  • Validation approach
  • Implementation and outlook
Annex 1 Revision - Sterilisation and Sterile Filtration (GMP Inspector’s View)
  • Most important changes in sections “sterilisation” & “sterile filtration”
  • Regulatory comparison of Annex 1 version 2008 and new Draft
  • GMP inspector’s comments (including PUPSIT)
The Implication of a new Annex 1 for a Global Pharmaceutical Company
  • Approach to assess and enforce required changes to current practice (Define action plan)
  • How to integrate Annex 1 requirements into a global pharmaceutical quality system to comply with “global” standards

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