Monographs on Vaccines and Immunosera - Revised Expert Guidance

Recommendation

9/10 May 2023
Heidelberg, Germany

Annex 2 & Co. - GMP Compliance for Biopharmaceuticals
Regulatory Requirements and Practical Implementation

At its 162nd session, the European Pharmacopoeia Commission (Ph. Eur.) approved a new edition of the Guide to the Preparation and Use of Monographs on Vaccines and Immunosera for Human Use. The document provides experts in the relevant pharmacopoeia groups with guidance on what information to include in the Ph. Monographs on vaccines and sera for human use. It also forms an important part of the harmonization of the style of the various monographs.

The new edition of the Guide takes into account the experiences of recent years in the preparation of monographs in this field and reflects the latest developments in Ph.

While the guide is aimed mainly at experts writing monographs on vaccines and sera, it also provides useful information to help users better understand the requirements and structure of these monographs. Thus it is aimed e.g. at

• Expert Group 15 (Vaccines and Immunosers for Human Use);
• Competent Authorities responsible for marketing authorisations for vaccines and immunosera;
• Official drug control laboratories (OMCLs);
• Manufacturers of vaccines and immune sera for human use;
• Bodies that procure vaccines and immune sera for healthcare; Public and private analytical laboratories working for one of the institutions above;
• The Ph. Eur. Secretariat and other departments of the European Directorate for the Quality of Medicine & Healthcare (EDQM).

The full document can be found at "Guide for the elaboration and use of monographs on vaccines and immunosera for human use".