Annex 1 Conference - Current Requirements for Sterile Manufacturing

Annex 1 Conference  -  Current Requirements for Sterile Manufacturing

Neuss, Germany

Course No 17010




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Dr (Ing) Jürgen Blattner, BSR
Walid El Azab, Steris
Dr Rainer Gnibl, GMP Inspector
Dr Friedrich Haefele, former Head Fill and Finish, Boehringer Ingelheim
Arjan Langen, GE Healthcare
Dr Jean Denis Mallet, ECA, former Head of the French Pharmaceutical Inspection Dpt. AFSSAPS
Franziska Petershagen, Vetter Pharma Fertigung
Matthias Schaar, Novartis Pharma Stein
Dr Helen Stöber,Vetter Pharma Fertigung
Dr Ingrid Walther, Pharma Consulting Walther, Chair ECA Annex 1 Task Force


This conference offers you a unique possibility to become acquainted with the new regulatory requirements of the revised second Draft of 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 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.


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 6,000 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.

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


Organisationals and Introduction – The Draft and its Issues
  •  Structure
  •  Wording
  •  Definitions
Future Sterile Manufacturing – an Authority Perspective
  •  Current challenges
  •  Regulatory developments
  •  Expectations
Modernisation and Implementation of Quality Risk Management (QRM) – Inspectors’ Experiences and Expectation

Industrial Experiences in QRM in Sterile Manufacturing
  •  Principles of risk assessment
  •  Dos and don’ts
  •  How to apply risk assessments within contamination control
 Authorities‘ Expectations on Contamination Control Strategy & Monitoring
  •  Environment
  •  Personnel
  •  Media Fill
Industrial Experiences on PST Regarding the Annex 1 Challenges
  •  The second draft: regulatory changes regarding APS
  •  Impact on the current media fill program at Vetter
  •  Industrial point of view – current experiences and discussion points
Environmental Monitoring
  •  Principles of risk assessment
  •  Dos and don’ts
  •  How to apply risk assessments within contamination control
Enhanced Requirements on Facilities and Utilities
  • Explicit requirements
    • 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
Annex 1 vs. US Guidance “Sterile Drug Products Produced by Aseptic Processing”
  •  Very brief history of the two guidances
  •  Main  accordances
  •  Some differences
Qualification in Sterile Manufacturing: Annex 1 and ISO 14644 – a Comparison
  •  Accordance and Differences
  •  The Issue with the Particle Sizes
  •  Qualification Challenges
Contamination Control Strategies
  •  Define a control strategy objective
  •  Understand the contamination control strategy concept
  •  Develop a contamination control strategy - share idea
  •  Assess the contamination control strategy Level
Access & Transfer into Clean Areas
  • Expectations on
    • Personnel
    •  Materials
    •  Airlocks
    •  Clothing
Annex 1 – Developments for RABS and Isolators
  •  Most important changes for biopharmaceutical manufacturing - section “barrier systems”
  •  Regulatory comparison of Annex 1 version 2008 and new Draft
  •  Industrial Experiences
Container Closure Integrity – State-of-the-Art Testing in Context of Annex 1
  •  Current Requirements
  •  Draft Annex 1 vs new Draft Annex 1
  •  Personal conclusions and Outlook
Sterilization & Sterile Filtration
  •  Definitions
  •  Requirements
  •  Validation
The Implication of a New Annex 1 for a Global Pharmaceutical Company

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