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       Antellis, your elemental solutions!
  • You are a pharmaceutical company, a CMO, a manufacturer of active pharmaceutical ingredients or excipients. You are faced to changes in heavy metal or elemental impurity regulations in drug products (ICH Q3D, USP <232>, Ph. Eur. 5.20): All of the batches of drug product must be compliant with these new guidelines within the next 2 or 3 years.
  • This is a big change for several reasons: risk analysis based controls, controls with new analytical technologies (ICP-MS or OES), and guidelines applicable to new marketing authorization applications and to authorized medicinal products. Thus there are numerous questions: Which elements to control? Which specifications? Which product to control (raw materials, APIs, finished products…)? Which analytical strategy to adopt (insourcing/outsourcing)?
  • Antellis answers to your questions and helps you in implementing these new guidelines. So, ready for change? Contact us!
 
  • Japan:
    ICH Q3D guideline was officially issued in Japan on 30th september 2015.
  • FDA:
    US FDA published the final Q3D Elemental Impurities guidance on 9th september 2015.

  • USP <232>:
    General chapter 232 - "Elemental impurities - Limits" will be made applicable on the 1st of January 2018!

  • ICH Q3D (1) :

    Guideline coming into effect in June 2016 for new marketing authorization applications!

  • ICH Q3D (2):

    Guideline coming into effect in December 2017 for authorized medicinal products!

  • USP <231>:
    The USP “heavy metal” chapter will remain in effect until the 1st of January 2018!

  • Revised USP <232>:
    Published in the Second Supplement to USP 38-NF 33, USP<232> specifications for elemental impurities now agree with ICH Q3D specifications.
  • French Research Tax Credit / CIR:

    Antellis is CIR accredited ("Crédit Impot Recherche" / French Research Tax Credit) for 2014, 2015 and 2016.