WHO TRS (Technical Report Series) 1010, 2018 Annex 6


WHO TRS (Technical Report Series) 1010, 2018 Annex 6

Good pharmacopoeial practices: Chapter on monographs for compounded preparations


Following the fiftieth meeting of the WHO Expert Committee on Specifications for Pharmaceutical Preparations, the guidance on good pharmacopoeial practices (GPhP) was published as Annex 1 to the report. The primary objective of the GPhP is to define approaches and policies in establishing pharmacopoeial standards with the ultimate goal of harmonization. In line with this objective, this guidance on monographs for compounded preparations has been developed outlining the structure and contents of such monographs.

1. Introduction:

Compounded preparations involve the preparation, mixing, assembling, altering, packaging and labelling of a medicine or drug-delivery device, in accordance with a licensed practitioner’s prescription, medication order or initiative based on the relationship between the practitioner, patient, pharmacist and compounder in the course of professional practice.

This section of the GPhP helps define good practices for developing pharmacopoeial monographs for compounded preparations, which will help ensure the quality of these preparations.

2. Monograph development:

Pharmacopoeial monographs for compounded preparations are generally developed by a pharmacopoeia and its expert committees rather than by donation from a manufacturer. Monographs for compounded preparations may include a stability-indicating assay and acceptable limits for the active pharmaceutical ingredient(s) (API(s)). Where required, a beyond-use date (BUD) or assigned shelf life  is included, based on suitable stability studies. Typical sources of pharmacopoeial monographs for compounded preparations include:

■ laboratory-conducted method development, validation and stability studies;

■ peer-reviewed literature, evaluated based on stringent criteria;

■ donated scientific data.

3. Quality of ingredients:

Ingredients specified in the definition and/or used in the formula in pharmacopoeial monographs for compounded preparations comply with relevant monographs for pharmaceutical substances and general monographs, if available.

See also pdf file:

WHO TRS (Technical Report Series) 1010, 2018 Annex 6:

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