Quality & complianceOfficial

CHMP endorses updated nitrosamine Q&A with higher intakes and longer CAPA timelines

🇦🇹 BASG · Fri 06 Nov 2026

Austria's BASG says the revised Q&A allows higher acceptable intakes under a less-than-lifetime approach, extends CAPA timelines to seven years and adds a polymer-bag risk factor.

The Austrian Federal Office for Safety in Health Care (BASG) reported on 6 November 2026 that the CHMP, in agreement with the CMDh, has endorsed an updated Q&A document on nitrosamine impurities. The document is aimed at marketing authorisation holders and applicants and supports implementation of the CHMP opinion issued under Article 5(3).

BASG says the new version reflects several changes to previously published guidance. One is higher acceptable intakes (AIs) for nitrosamine impurities, resulting from full application of the less-than-lifetime (LTL) approach under ICH M7. This applies to suitable medicines with a treatment duration of under 10 years and is covered in Q&A 24.

The period for implementing corrective and preventive actions (CAPAs) is extended from three to seven years under certain conditions (Q&A 22). The Q&A also adds a new risk factor for nitrosamine formation linked to parenteral medicines in polymer bags (Q&A 4).

Two further changes concern limits. The approach for setting AI limits for nitrosamines now also applies to other N-nitroso compounds (Q&A 23), and the limits for nitrosamines originating from excipients have been updated (Q&A 10). BASG's notice does not give the new figures or the specific conditions for the longer CAPA period, which are in the Q&A document itself.

What it means for your team

  • Review the revised Q&A 24 to see whether products with treatment durations under 10 years qualify for higher AIs under the LTL approach.
  • Check CAPA plans against Q&A 22, since the seven-year implementation period applies only under certain conditions.
  • Update risk assessments for parenteral products in polymer bags (Q&A 4) and for nitrosamines from excipients (Q&A 10).
  • Consider whether other N-nitroso compounds in the portfolio now fall under the AI-setting approach (Q&A 23).

Official source: BASG ↗

Article written by VigiEye from the official source (BASG). AI-assisted; check the source before acting.

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