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22-26 February 2021

published 1 Mar 2021

New Q&A on comminuted plants and herbal extracts GMP requirements

The EMA has released a new Q&A on GMP requirements applicable to the initial extraction steps in the manufacture of non-transgenic comminuted plants and herbal extracts that are used as active substances. The Q&A states that EU Good Manufacturing Practice (GMP) Part II – Basic Requirements for Active Substances used as Starting Materials lays out the requirements for the manufacture of herbal extracts as active substances, and the supplementary guidance also applies as per EU GMP Annex 7 – Manufacture of Herbal Medicinal Products. Transgenic plants are covered separately by EU GMP Annex 2. The Q&A also provides guidance for exceptional circumstances where the early manufacturing steps such as expression from plants and distillation are performed in the field.

Updated Ph. Eur. dosage form monographs and general chapters

The Ph. Eur. Commission has adopted revised versions of three dosage form monographs, two general chapters and also one new general chapter:

· Eye preparations (1163) – New requirements concerning the test for sub-visible particle contamination have been added for eye drops and eye lotions.

· Ear preparations (0652) – A new section on ear sprays has been created.

· Foams, medicated (1105) – The sterility test and the labelling section have been deleted in order to avoid duplication of information from the dosage form monographs that refer to this text.

· Disintegration of tablets and capsules (2.9.1) – The section concerning Test B applicable for tablets and capsules larger than 18 mm has been revised.

· Uniformity and accuracy of delivered doses from multidose containers (2.9.27) – The revised text makes it possible to conduct the test based on volume measurements.

· Particulate contamination: sub-visible particles in non-injectable liquid preparations (2.9.53) – This applies to certain eye preparations.

The texts will be published in July 2021 in Supplement 10.6 of the Ph. Eur. and will become legally binding on 1st January 2022.

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