10th Edition of The International Pharmacopoeia

Recommendation
18-20 November 2025
Heidelberg, Germany
GMP and FDA Compliance in Pharmaceutical Development and IMP Manufacturing
The International Pharmacopoeia (Ph. Int.) contains recommended procedures for analysis and specifications for pharmaceutical substances (active pharmaceutical ingredients, APIs) and dosage forms. According to the WHO (World Health Organization) it is intended to serve as source for reference or adaptation by any WHO Member State. The Ph. Int. has legal status, whenever a national or regional authority refers to it in appropriate legislation.
Compared to other pharmacopoeias (e.g. Ph. Eur., USP, JP), "priority is given to medicines included in the WHO Model List of Essential Medicines and to medicines which are important for WHO health programmes and for which other pharmacopoeias do not offer any test specifications". Moreover, the needs of developing countries are taken into account.
The International Pharmacopoeia, Tenth Edition, 2020 - Content Overview
- General Notices (includes information on storage, stability, labelling, identity, tests & assays, accuracy and precision, calculation of results, impurities, reference substances, etc.)
- Appendices to the General Notices
Abbreviations and symbols
Units of measurement
Names, symbols, and relative atomic masses of certain elements - Monographs
Pharmaceutical substances
Dosage forms
Radiopharmaceuticals - Methods of Analysis
1. Physical and Physicochemical Methods
2. Chemical methods
3. Biological methods
4. Methods for materials of plant origin
5. Pharmaceutical technical procedures - Infrared reference spectra
- Reagents, test solutions and volumetric solutions
- Supplementary information
The International Pharmacopoeia is available online free for use.
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