Pharmaceutical Microbiology Working Group Update Q4/2025

Board Developments
An on-site Board Meeting was held at PharmaLab on 24 November 2025

Guideline Developments

• The creation of the draft Q&A document is delayed. Barbara Gerten will not be able to complete it before her retirement in January. Thomas Meindl will check potential Labor LS support/involvement, and Virginie will be the point of contact for bioMérieux. Barbara will share the current draft with Thomas and Virginie. New due date for the Q&A-document is Q2/26.
  
• Guidance document "GMP Readiness of NGS-Applications"
  Ulrich Herber presented the table of content of the document. The paper will cover virus and microbial contaminations. Product characterization will be addressed in additional documents, chapters etc. The draft should be completed by end of Jan 26. Oleg, Erik Clement and Isabelle Bekeredjian-Ding volunteered to review draft.

Surveys
The group supported the british  NC3Rs Survey on MAT. First results were presented at PharmaLab from the Nc3Rs.

Miscellaneous

• Document “Specified/objectionable microorganisms for ATMPs”
  Oleg will share an initial summary of his thoughts on this topic with the ECA “Pharmaceutical Microbiology”-Board by April 2026. The initial draft will subsequently be reviewed by the Advisory Board members. The feedback should be reconciled at the upcoming Advisory Board meeting in November 2026.
• Risk assessment “Microbial Control Concept for ATMPs”
  Oleg will share the draft of the paper by October 2026. The members of the Advisory Board can then review the draft until the meeting in November, and we can reconcile the content during the Advisory Board meeting in November.
  Note: Marsha Steed and Jim Polarine started work on a similar document. They will focus on CCS for ATMPs. Axel Schroeder will provide a draft of Marsha’s and Jim’s paper to Oleg so that he can avoid redundancies when creating his draft.