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This is what you need to know

if you are working with Annex 1

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Annex 1 Revision
- The Training Course


  • April 10th | Malmö

  • April 11th | Stockholm 



A joint working group from the EMA (European Medicines Agency) and PIC/S (Pharmaceutical Inspection Co0peration Scheme) have been working on a major revision of the GMP Guidance for Sterile Products (Annex 1) for around 2 years.


The revision has been long awaited because the 2008 version of Annex 1 has many confusing requirements, and is out of date in many areas such as isolators, single use systems, and environmental monitoring. At the end of December 2017, a draft was published for public comment and review.


BioTekPro is providing this training course to explain “THE LIKELY CHANGES” and to learn about the industry feedback to the EMA.revision. NEWS ABOUT THE FEEDBACK - SEE BELOW


Annex 1 Revision - The Training Course

In this important one day training course, we will focus on the revision process, the main changes, and some of the issues of concern already identified by industry.



The main areas that will be summarised in this

Annex 1 Revision Training Course are:


  • The joint EMA and PIC/S revision process explained:

    • Drafting.

    • Review by Regulators.

    • Draft publication for public scrutiny and comment.

    • Submission and consideration of comments by the EMA & PIC/S.

  • Some important principles in the revision:

    • The scale and scope of revision (15 to 50 pages).

    • How the principles of QRM are embodied.

    • Application scope.

    • The differences between the suggested new and old version of Annex 1.

  • The application of Annex 1 to non-sterile product manufacturing.

  • Isolators, RABS and Cleanrooms.

  • Special processes such as Blow-Fill-Seal.

  • Clean room and clean-zone classification and monitoring. Very important proposals here.

  • New requirements for WFI.

  • Sterilisation, including PUPSIT.

  • Process simulation and media-fills.

  • Single use and closed systems.

  • Planning for the changes.




Feedback following the UK PHSS Annex 1 meeting

BioTekPro’s course on Annex 1 will include Regulatory and Industry feedback following the

UK PHSS Annex 1 meeting on 12th March. Speakers at the meeting included experts from GSK, Pfizer and Mr Andrew Hopkins (UK MHRA), Rapporteur for the Inspector’s Working

Party responsible for drafting the revision.


Some more insight into the revision will be shared:

  • Some of the IWP’s essential objectives.

  • The next stages in the revision process
    – A second draft for public comment ??? – Timeline.

  • How comments are being considered.

  • Industry response. Support and concerns.



Course fee

SEK 12 500:- (excl. VAT) including course notes, certificate, lunch and coffee


Early-Bird Discount

Registration 1 month prior course date = SEK 1 000:- Discount



  • Gordon Farquharson, Critical Systems Ltd

  • Matts Ramstorp, BioTekPro AB


Registration / Questions

Questions? Call +46 (0)40 - 13 82 50, or +46 (0)708 - 13 05 65


Register by sending an email to


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