New Edition of the Technical Guide for the Elaboration of Ph. Eur. Monographs
The European Pharmacopoeia (Ph. Eur.) Commission published the 8th edition of the Technical Guide for the Elaboration of Monographs. The guide helps when drafting monographs and transferring analytical methods into a compendial procedure. The previous version of the guide dated back to 2015.
Highlights of the New Edition
The 8th edition contains, among others,
- The revision of the General Notices (1.),
- The implementation of the new General Chapter Balances (2.1.7),
- The harmonization of the General Chapter, Degree of coloration of liquids (2.2.2),
- The switch to a molecular sieve from phosphorous pentoxide in the revised General Chapter Loss on drying (2.2.32),
- A more detailed description for second identification tests,
- Information on when a reporting threshold should be included (depending on the analytical procedure used, i.e., external standardization or normalization) and whether one impurity or several (including the total) are to be quantified,
- An updated policy on genotoxic impurities following the ICH M7 guideline.
The revised technical guide also applies to the newly introduced Ph. Eur. medicinal product monographs.
Other available Ph. Eur. Technical Guides
Other helpful Technical Guides for the Elaboration of Ph. Eur. Monographs dedicated to special classes of substances and products, are the following ones on:
- Medicinal products containing chemically defined active substances
- Vaccines and immunosera for human use
- Synthetic peptides and recombinant DNA proteins
- Homoeopathic preparations
- Human plasma-derived products
- Radiopharmaceutical preparations
- Immunological veterinary medicinal products
- Vaccines for veterinary use
- Fatty oils and derivatives
- Herbal drugs and herbal drug preparations
More information is available in the EDQM Newsroom and under Ph. Eur. Technical Guides.
Related GMP News
02.07.2025FDA Warning Letter: Missing Testing, No Stability Data, and Inadequate Raw Material Controls
25.06.2025FDA Warning Letter: "Memory-Based Manufacturing" and Lack of Analytical Testing
11.06.2025USP informs about Monographs affected by the Revision of NMR Chapters <761> and <1761>
28.05.2025FDA Warning Letter for Chinese Manufacturer: Inadequate Testing and Stability Program Deficiencies