This activity involves the General European OMCL Network only.

Background

Market Surveillance Studies (MSS) are carried out on commercialised medicines, particularly on those having a national marketing authorisation.

Products are tested according to a common protocol and on the basis of national sampling procedures.

To ensure that the same types of medicines are of comparable quality in the different member states, these studies are multilateral. Several are organised yearly. They look at different types of finished products for a given active substance and at herbal drugs.

Where a need is identified, the results of these studies could support revision of the relevant European Pharmacopoeia monographs and/or general chapters and methods.

Since 1999, more than 60 MSSs have been organised within the Network and more than 4470 finished medicinal product samples have been tested in order to control the quality of medicines available on the European market. This position paper adopted in May 2023, highlights the benefits of MSS. 

Achievements in 2023

Olanzapine APIs and tablets (MSS060)

An MSS on Olanzapine APIs and tablets (MSS060) was finalised in 2023. Twenty-one OMCLs from 10 European countries participated in the study, which focused on the analysis of key parameters of olanzapine APIs and generic olanzapine tablets to assess their compliance with authorised specifications. In total, 36 API samples and 209 tablet samples were analysed.

All the tablet samples complied with respect to the different parameters described in the protocol (identification, assay, content uniformity and dissolution). In case of the API, eight samples did not comply with the specifications of the Ph. Eur. monograph for related substances. For three of them, the specification and method differ from those of the Ph. Eur. monograph on olanzapine and the samples complied with the company's specifications if tested in accordance with the company's method.

Breaking of Glass Ampoules (MSS061)

This study, which was launched in 2021 and finalised in 2023, was based on signals reported by an OMCL from their national market. The findings were related to glass fragments found in liquid dosage forms filled in glass ampoules with one-point cut (OPC) systems after opening, which were considered as a potential issue applicable to all markets.

Nine laboratories from 9 European countries participated in the study, during which 2190 ampoules, from 138 samples, were tested. Considering all types of breaking systems, glass particles were formed in 31% of the ampoules opened and were found in the fluid extracted from 23% of the ampoules. Ampoules with OPC breaking systems seemed to be less prone to the formation of glass particles when opening by hand than other systems (breaking rings, double tip systems, etc...). The results of the study confirmed the conclusion that this quality defect is not related to the product, the batch, or the manufacturer, but only to the packaging material of glass ampoules.

The MSS061 Breaking of glass ampoules summary report can be accessed here.

Rosuvastatin APIs and tablets (MSS063)

An MSS on Rosuvastatin APIs and tablets (MSS063) was launched in 2023. Fourteen OMCLs from 14 European countries enrolled in the study, which focuses on the analysis of key parameters of rosuvastatin APIs and generic rosuvastatin tablets to assess their compliance with authorised specifications.

The EDQM’s coordination activities with respect to the MSS “classical” programme are ISO 9001 certified by AFNOR Certification and audited on a regular basis.