Annex 1 – Changes, Challenges and Consequences

Annex 1 – Changes, Challenges and Consequences

Berlin, Germany

Course No 16894


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Maximilian Augustin, Roche

Walid El Azab, Steris Corporation, Belgium

Dr Rainer Gnibl, Local Government of Upper Bavaria

Arjan Langen, MSD, The Netherlands

Dr Daniel Müller, Local Government of Baden Württemberg

Robert Schwarz, Campus Vienna, Austria

Magnus Stering, Sartorius Stedim Biotech

Dr Ingrid Walther, Pharma Consulting Walther


This special course 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 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.
But the currently published document represents for the first time a complete revision wit the focus to give a more structured guidance, including state of the art principles like Quality Risk Management and pay attention to new technologies and innovative processes. It includes now new sections, as 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


Structure, Wording, Definitions - the current Draft

  • Structure and Scope
  • The Issue with Wording and Definitions
  • Impact for the User
Classification & Qualification of sterile Facilities & Utilities – Inspector´s view
  • Holistic lifecycle structure (overview)
  • Qualification stages
  • Traceable documentation structure
  • Essentials from Annex 1 - DRAFT
Sterilisation and sterile Filtration – Inspector´s view
  • New structure from Annex 1 - DRAFT
  • Details from new chapter “sterilisation” & “sterile filtration”
  • Filter integrity testing (incl. PUPSIT)
  • Sterilisation acc. Annex 1 in line with requirements from Annex 17?
  • Overview of requirements
  • Current standard
  • Driving standard considering updated regulations
Personnel - Clothing, Behaviour and more
  • Most important changes of Annex 1 (draft) in section “Personnel”
  • Garment and Gowning
  • Qualification and training of workers
  • Surveillance of health status and hygienic behaviour
  • GMP inspector’s comments
Consequences on Microbiological Contamination Control and Environmental Monitoring expected by industry
  • General concerns within contamination control
  • Contamination control strategy
  • Consequences for Environmental Monitoring Program
Cleaning and Disinfection – in the light of Annex1
  • Discussion of the different regulatory requirements
  • Rotation discussion – How to be globally compliant?
  • Design a robust Cleaning and disinfection program including rinse program: Beyond regulatory compliance – best practices for cleaning and disinfection program
Media Fill/Aseptic Process Simulation regarding the new Annex 1
  • Comparison of the main regulations regarding Media Fills: EU GMP Guide new Annex 1, FDA Aseptic Guide, PIC/S Guide ‘Recommendations on the Validation of Aseptic Processes’
  • Main changes compared to still valid Annex 1
  • Implementation of new requirements into routine
Comparison with other relevant Documents
  • FDA Aseptic Guide
  • ISO 14644
  • Others ( e.g. PIC/S, WHO etc.)
Barrier Systems and Isolators
  • Changes from the former revision
  • Comparison Cleanroom, RABS and Isolator
  • “Is the classical cleanroom dead?” - Impact on aseptic processing
QRM – Quality Risk Management in the light of Annex 1
  • Quality Risk Management (QRM) in manufacturing of sterile medicinal products
  • Pharmaceutical Quality System, QRM, and risk assessment(s)
  • Most important changes of Annex 1 (draft) regarding QRM principles
  • GMP inspector’s comments

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