New Edition of the Technical Guide for the Elaboration of Ph. Eur. Monographs

Recommendation

15/16 November 2023

Serialization/Aggregation - Live Online Training
Requirements, Challenges & Solutions

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.