Live Online Conference - Annex 1 - Current Requirements for sterile Manufacturing

Live Online Conference -  Annex 1 - Current Requirements for sterile Manufacturing

Course No 18393

All times mentioned are CET.


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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
Stephan Löw, CSL
Dr Jean Denis Mallet, ECA, former Head of the French Pharmaceutical Inspection Dpt. AFSSAPS
Christina Meissner,  AGES, Austria
Franziska Petershagen, Vetter Pharma Fertigung
Dr Helen Sauter, Vetter Pharma Fertigung
Matthias Schaar, Novartis Pharma Stein
Dr Franz Schönfeld, GMDP inspector for EMA and local authorities, Germany
Dr Alexander Stoll, Fresenius Kabi
Dr Ingrid Walther, Pharma Consulting Walther, Chair ECA Annex 1 Task Force


This Live Online 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 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.


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.

Target Group

This Live Online 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

For our webinars, we use Cisco WebEx, one of the leading suppliers of online meetings.

At you can check if your system meets the necessary requirements for the participation at a WebEx meeting and at the same time install the necessary plug-in.  Please just enter your name and email address for the test. If the installation is not possible because of your rights for the computer system, please contact your IT department. WebEx is a standard nowadays and the necessary installation is fast and easy.


Programme Day 1
Provisional timetable, the actual schedule may vary depending on the situation

09.00 – 09.10 h
Organisationals and Introduction

09.10 – 09.30 h
The Draft, the Consultation and Its Issues

09.30 – 10.00 h
  • Future Sterile Manufacturing – an Authority Perspective
  •  Current challenges
  •  Regulatory developments
  •  Expectations
10.00 – 10.30 h
Modernisation and Implementation of Quality Risk Management (QRM) – Inspectors‘ Experiences and Expectations
10.30 – 11.00 h
Industrial Experiences in QRM in Sterile Manufacturing
  •  Principles of risk assessment
  •  Dos and don’ts
  •  How to apply risk assessments within contamination control
11.00 – 11.15 h  Break

11.15  – 12.30 h
Authorities Expectations on Contamination Control Strategy & Monitoring
  •  Environment
  •  Personnel
  •  Media Fill
12.30 -13.00 h
Questions and Answers

13.00 – 14.00 h  Break

14.00 - 14.45 h
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
14.45 -15.30 h
Environmental Monitoring
  •   Principles of risk assessment
  •  Dos and don’ts
  •  How to apply risk assessments within contamination control
15.30 – 15.45 h  Break

15.45 – 16.30 h
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?
16.30 – 17.15 h
Annex 1 vs. US Guidance “Sterile Drug Products Produced by Aseptic Processing”
  •  Very brief history of the two guidances
  •  Main  accordances
  •  Main differences
17.15 – 18.00 h
Question and Answers

Programme Day 2

08.30 – 09.15 h
Qualification in Sterile Manufacturing: Annex 1 and ISO 14644 – a Comparison
  •  Accordance and differences
  •  The Issue with the particle sizes
  •  Qualification challenges
09.15 – 09.45 h
Access & Transfer into Clean-Areas  – Expectations on
  •  Personnel
  •  Material
  •  Airlocks
  •  Clothing
09.45 – 10.45 h
Cleaning and Disinfection Requirements as Part of CCS
  • Regulatory requirements and industrial needs
  •  Elements of a robust cleaning and disinfection programme
  •  Selection and validation of disinfectants
  • Ongoing control of effectiveness
10.45 – 11.00 h  Break

11.00 – 11.45 h
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
11.45 -12.15 h
Questions and Answers

12.15 – 13.15 h  Break

13.15 – 14.15 h
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
14.15 – 15.15 h
Sterilization & Sterile Filtration
  •  Definitions
  •  Requirements
  •  Validation PUPSIT
 15.15 – 15.30 h  Break

15.30 – 16.15 h
The Implication of a New Annex 1 for a Global Pharmaceutical company
16.15 – 17.00 h
Questions and Answers

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