Hi everyone!

Today we are going to discuss about the CEP/COS (Certification of suitability of European Pharmacopoeia monographs/ Certificate of suitability)!
Before filing a CEP, Let’s have a look about its history.


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European Directorate for the Quality of medicines and Healthcare was established in the year 1992 as a pilot scale and took over charge as a routine procedure in the year 1994 for the chemical substances. It was then expanded in the year 2003 and included herbal drugs and herbal drug preparations.

The aim of the EDQM is to assess whether the relevant European Pharmacopoeia monograph(s) can be used to adequately to control the quality and impurity profile of an API or excipient produced and/or distributed by the manufacturer. The procedure is complemented by an inspection programme of manufacturing and/or distribution sites, involving a network of around 100 assessors and 30 inspectors from 24 different national competent authorities and the EDQM.

Why to file a CEP?

The Certification procedure is not compulsory – it is a service that is offered to the API and excipient manufacturers, who can use a Certificate of Suitability (CEP) in an application for a new market authorisation (MAA) or for a variation of an existing MAA.


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The manufacturer of a substance will be able to provide proof that the quality of the substance is suitably controlled by the relevant monographs of the European Pharmacopoeia by means of a certificate of suitability granted by the Certification Secretariat of the European Directorate for the Quality of Medicines (EDQM) To apply for a certificate a manufacturer will submit a detailed dossier (Refer ICH M4 CTD) which may also contain confidential data.

The procedure is intended to be applied for the assessment of quality with regards to the criteria of the monograph(s) as appropriate.

The certificate of suitability certifies that by applying the relevant monographs of the European Pharmacopoeia, if necessary with an annex appended to the certificate, it is possible to check whether or not the quality of the substance is suitable for use in medicinal products. In other words, it ensures that all possible impurities and contamination from this particular route of manufacture (including source materials), genotoxic impurities, elemental impurities that can be fully controlled.

The CEP certification procedure can be applied for the following substances:

1. Organic or inorganic substances (active or excipients), manufactured or extracted.

2. Substances produced by fermentation as indirect gene products, which are metabolites of microorganisms, irrespective of whether or not the microorganisms have been modified by traditional procedures or r-DNA technology (see the monograph Products of Fermentation).

3. Products with risk of transmitting agents of animal spongiform encephalopathies(TSE)

The certificate of suitability will be delivered in preference to the manufacturer of substances intended for pharmaceutical use. In special cases where the holder will not be the manufacturer but an authorised agent, a formal agreement is required.

The Certification procedure centralises the evaluation of data for the benefit of regulatory authorities and industry alike, thus saving time and resources. For example, on average it takes three days for a regulatory authority to assess an Active Substance Master File (ASMF), which is the document submitted by a manufacturer of a medicine as part of its application for MAA (the ASMF contains complete information on an API or finished drug dosage form). If the CEP included in the ASMF is used in 10 countries, this assessment only needs to be done once, thus saving 27 days and the corresponding resources.
Also, the Certification procedure provides the European Pharmacopoeia Commission with current information on the quality of substances on the European market, thus helping to identify whether or not a revision of specific European Pharmacopoeia monographs is needed.
CEPs – which are referred to in EU pharmaceutical legislation – are recognised by the European Pharmacopoeia member states and by a number of other countries and regions, such as Australia, Canada, New Zealand, Saudi Arabia, Singapore, South Africa, Taiwan and Tunisia. An increasing number of licensing authorities worldwide accept CEPs to support (fully or partially) the data related to the quality of APIs used in medicinal products.
In order for a specific manufacturer to be granted a CEP, the EDQM’s panel of assessors (drawn from national medicines agencies throughout Europe) review a detailed dossier submitted by the manufacturer.
This dossier describes the manufacturing process and the tests performed on the raw materials and on the substance produced, as well as the necessary in-process controls.
The manufacturer must demonstrate that its product complies with the quality standards required by the European Pharmacopoeia and EU legislation and, in particular, that the monograph can be used to control impurities. The applicant must also agree to comply with the relevant Good Manufacturing Practice (GMP) as defined in Part II of the EU GMP Guide, and to accept a site inspection at any time at the request of the application.

After complete assessment of the CEP, the manufacturer finally receives the CEP certificate, which is valid for 5 years. If there is a change in the manufacturing process or change in the content of the dossier, the CEP can be revised.


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