CEP holders are invited to submit feedback on draft monographs for fifteen substances.

digital-concept-compliance

The European Directorate for the Quality of Medicines & HealthCare (EDQM) has published new draft revised European Pharmacopoeia (Ph. Eur.) monographs in Pharmeuropa 38.3, tightening its compliance requirements for fifteen chemical substances.

Comments are now open for Holders of Certificates of suitability to the monographs of the European Pharmacopoeia (CEPs) to share their feedback on the monographs in advance of their adoption by the European Pharmacopoeia Commission. Once enforced, the monographs will become official quality standards for the corresponding substances.

In the Ph. Eur. draft revised monographs, these substances are:

  • Cyproterone acetate (1094)
  • Deferasirox (2933)
  • Donepezil hydrochloride (2582)
  • Fluoxetine hydrochloride (1104)
  • Heparin calcium (0332)
  • Heparin sodium (0333)
  • Hydrocortisone (0335)
  • Ipratropium bromide monohydrate (0919)
  • Macrogols (1444)
  • Potassium citrate monohydrate (0400)
  • Riboflavin sodium phosphate hydrate (0786)
  • Sodium nitroprusside dihydrate (0565)
  • Thiocolchicoside crystallised from ethanol (2896)
  • Thiocolchicoside hydrate (2814)

Comments on these revised draft monographs should be submitted by 30 September, as follows:

  • Companies located in a European Pharmacopoeia Member State can send comments through their relevant National Pharmacopoeia Authority
  • Companies located in a non-Member State country should provide feedback directly using the EDQM HelpDesk (topic 04-European Pharmacopoeia & International Harmonisation).

A separate major development in the quality control arena earlier this year was a key monograph revision supporting the industry’s goal of transitioning away from animal-based testing. The European Pharmacopoeia required that pharmaceutical manufacturers adopt animal-free alternatives to traditional pyrogen testing, such as the monocyte-activation test or the bacterial endotoxins test (BET). It sets a new standard for bacterial endotoxins testing (BET) in Europe.

Additionally, in January, the Ph. Eur. introduced a new general chapter on quality of data 5.38. It is designed to help pharmaceutical manufacturers make quality-related decisions required for their transition towards digitalisation.

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