Medicines

WHO Expert Committee on Specifications for Pharmaceutical Preparations

TRS 970 - Forty-sixth report

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Authors:
WHO

Publication details

Number of pages: 250
Publication date: June 2012
Languages: English
ISBN: 978 92 4 120970 0

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Correction to Annex 6, Recommendations for quality requirements when artemisinin is used as a starting material in the production of antimalarial active pharmaceutical ingredients

Please note that on page 233 of the forty-sixth report of the WHO Expert Committee on Specifications for Pharmaceutical Preparations the specification on impurity A (artemisitene) (first bullet point) should read:

  • the area of any peak corresponding to impurity A, when multiplied by a correction factor of 0.027 is not greater than 0.2 times the area of the peak in the chromatogram obtained with solution (3) (0.2%);
    We apologize for any inconvenience this may cause.

A member of the WHO Secretariat was inadvertently omitted from the List of participants:

Mr Vimal Sachdeva, Prequalification Programme, Quality and Safety: Medicines, Essential Medicines and Health Products, WHO, Geneva, Switzerland

The Expert Committee on Specifications for Pharmaceutical Preparations works towards clear, independent and practical standards and guidelines for the quality assurance of medicines. Standards are developed by the Committee through worldwide consultation and an international consensus-building process.

The following new guidelines were adopted and recommended for use: Development of monographs for e International Pharmacopoeia; WHO good manufacturing practices: water for pharmaceutical use; Pharmaceutical development of multisource (generic) pharmaceutical products – points to consider; Guidelines on submission of documentation for a multisource (generic) finished pharmaceutical product for the WHO Prequalification of Medicines Programme: quality part; Development of paediatric medicines: points to consider in formulation; Recommendations for quality requirements for artemisinin as a starting material in the production of antimalarial active pharmaceutical ingredients.