10th Edition of the Ph. Eur.

Recommendation

5-7 November 2024
Hamburg, Germany

GMP meets Development
GMP and FDA Compliance in Pharmaceutical Development and IMP Manufacturing

The 10th Edition of the Ph. Eur. consists of new texts (amongst others, 5.25. Process Analytical Technology, PAT) as well as all current texts from the 9th Edition, some of which have been revised or corrected. 

As of the 10th Edition of the Ph. Eur.,

• revised and / or corrected parts of texts are indicated by vertical lines (print version),
• horizontal lines indicate where parts of texts have been deleted (print version),
• a QR Code is included at the start of each text, providing a link to further information (e.g. the Knowledge database),
• the wording used in the calculation of percentage contents in tests for related substances has been modified to specify the full name of the substance (i.e. including counter-ions, hydrates etc.),
• tests using diphosphorus pentoxide, mainly tests for loss on drying, have been modified to avoid the use of this substance due to its toxicity,
• the names and descriptions of the reagents used to describe stationary GC phases have been revised,
• ‘Tamper-proof ’ has been replaced by ‘tamper-evident’,
• reference to general chapter 2.8.23. Microscopic examination of herbal drugs has been added when microscopic examination is carried out using a powder with a non-standard sieve size,
• the terms ‘coarse’ and ‘coarsely’ have been deleted from ‘coarse powder’ and ‘coarsely powdered herbal drug’ (2.9.12. Sieve test),
• results are expressed in per cent instead of per cent m/m in the tests 2.8.16 Dry residue of extracts and 2.8.17 Loss on drying of extracts.

The 10th edition of the Ph. Eur. will be released in July 2019 and will be updated with eight supplements over the next 3 years (10.1 to 10.8). The new and revised Texts of the 10th Edition will become official on 1 January 2020.