European Pharmacopoeia 5.17.2

[Renau Sheard]

TheEuropean Pharmacopoeia[1] (Pharmacopoeia Europaea, Ph. Eur.) is a major regional pharmacopoeia which provides common quality standards throughout the pharmaceutical industry in Europe to control the quality of medicines, and the substances used to manufacture them.[1] It is a published collection of monographs which describe both the individual and general quality standards for ingredients, dosage forms, and methods of analysis for medicines.[1] These standards apply to medicines for both human and veterinary use.[1]

The European Pharmacopoeia has a legally binding character. It is used as an official reference to serve public health,[1] and is part of the regulatory requirements for obtaining a Marketing Authorisation (MA) for a medicinal (human or veterinary) product.[1] The quality standards of the European Pharmacopoeia apply throughout the entire life-cycle of a product, and become legally binding and mandatory on the same date in all thirty-nine (39) signatory states, which include all European Union member states.

Several legal texts make the European Pharmacopoeia mandatory in Europe.[1] The Convention on the Elaboration of a European Pharmacopoeia (ETS No. 50)[2] which was adopted by the Council of Europe in 1964, laid the groundwork for the development of the European Pharmacopoeia. In 1994, a Protocol (ETS No. 134)[1][3] was adopted, amending the convention to prepare for the accession of the European Union (EU), and defining the respective powers of the European Union and its member states within the European Pharmacopoeia Commission.

European Union Directive 2001/82/EC[4] and Directive 2001/83/EC,[5] (as amended) state the legally binding character of European Pharmacopoeia texts for Marketing Authorisation Applications (MAA). All manufacturers of medicines or substances for pharmaceutical use therefore must apply the European Pharmacopoeia quality standards in order to be able to market and use these products in Europe.[1]

As of February 2020, thirty-nine (39) member states and the European Union are signatories to the Convention on the Elaboration of a European Pharmacopoeia. There are 30 observers in all: five European countries, 23 non-European countries, the World Health Organization (WHO) and the Taiwan Food and Drug Administration (TFDA) of the Ministry of Health and Welfare.

While the European Directorate for the Quality of Medicines & HealthCare (EDQM), a directorate of the Council of Europe, provides scientific and administrative support for the European Pharmacopoeia, the governing body is the European Pharmacopoeia Commission. The European Pharmacopoeia Commission determines the general principles applicable to the elaboration of the European Pharmacopoeia. It also decides the work programme, sets up and appoints experts to the specialised groups responsible for preparing monographs, adopts these monographs, and recommends dates for the implementation of its decisions within the territories of the contracting parties.

This Commission meets in Strasbourg, France, three times a year, to adopt texts proposed by its groups of experts, and to decide on its programme of work and general policies. Items are added to the work programme in response to requests received by the European Directorate for the Quality of Medicines & HealthCare from the member states and their national authorities, industry or experts from around the world, based on current scientific and health issues. Each national delegation has one vote. In all technical questions, the decisions of the commission are taken by a unanimous vote of the national delegations that cast a vote. Member states' representatives mostly come from health authorities, national pharmacopoeia authorities and universities; and are appointed by the national authorities on the basis of their expertise. Representatives of the thirty (30) observers are invited to attend the sessions, but cannot vote.

The current chair of the commission is Prof. Salvador Caigueral, elected in March 2022.[6] The term of the chair is three years, and runs in parallel with other members of the commission's Presidium.[6]

The first edition of the European Pharmacopoeia was published in 1969, and consisted of 120 texts. The 11th edition, currently applicable, was published in July 2022. The Ph. Eur. is applicable in 39 European countries and used in over 130 countries worldwide.[7] Nowadays it contains over 3000 texts (the monographs), covering all therapeutic areas and consisting of:

A new edition of the European Pharmacopoeia is published every three years: in both English and French,[7] by the Council of Europe. It is made available in print and electronic (online and downloadable) versions; the online version is also accessible from smartphones and tablet computers.[7]

The General Chapter 2.1.7 "Balances for Analytical Purposes" was published in July 2021 and it is legally binding since January 2022. It is a mandatory requirement for the quality control of medicines in European member states, or for any pharmaceutical company who exports into the European market. It has a similar legal status to the USP compendium in the United States.

This white paper explains all the elements of Chapter 2.1.7 "Balances for analytical purposes", including the scope, the main principles, the role of calibration in a quality management system, and what specific performance checks (also known as routine tests) are required to assess the accuracy and precision of a weighing instrument.

As the calibration of balances is a mandatory requirement of General Chapter 2.1.7, METTLER TOLEDO offers the certificate "European Pharmacopoeia General Chapter 2.1.7 Balances for Analytical Purposes". The certificate documents the assessment of a balance against the requirements stipulated for precision and accuracy. This assessment is also available in an independent document against the identical requirements stipulated by USP General Chapter 41.

The European Pharmacopeia (Ph. Eur.) is the single reference work for the quality control of drugs in Europe. It is therefore also binding for Pharmaceutical companies in other regions of the world who intend to export into the European market. As such, it has a similar legal status to the USP Compendium in the United States and is enforced by regulatory bodies as part of compliance with Good Manufacturing Practice.

The scope of the General Chapter 2.1.7 covers balances for analytical purposes. Therefore, any weighing described in a monograph of the European Pharmacopoeia must comply with the principles of the chapter.

Our Accuracy Calibration Certificate in combination with the certificate "European Pharmacopoeia General Chapter 2.1.7 Balances for Analytical Purposes" documents the assessment of the balance against the requirements stipulated for precision and accuracy, while GWP Verification creates the quality framework under which the individual tests and assessments are conducted and documented. It provides a clear risk-based test strategy on suggested frequencies for calibration and the individual routine tests. Therefore, GWP Verification creates the quality framework under which the individual tests and assessments are conducted and documented.

Yes. Each certificate has dedicated statements to document compliance according to the specific pharmacopoeia. When references are made in the customer documentation, they can be specifically related either to Ph. Eur. General Chapter 2.1.7. or to USP General Chapter 41.

It is not a mandatory requirement, but it is strongly recommended for traceability. If a calibration is carried out with no adjustment afterwards, it means that the as found calibration already fulfils the requirements of the European Pharmacopoeia. In this specific case, an as left calibration is obsolete and the as found calibration data are considered to be also as left calibration data.

The European Pharmacopoeia (Ph.Eur) is a pharmacopoeia published by the European Directorate for the Quality of Medicines and Healthcare (EDQM) under the auspices of the Council of Europe and all the signatory states to Treaty Number 050. The Ph.Eur is the de facto official pharmacopoeia of the European Union.

Through its monographs and general chapters, the Ph.Eur fosters public health by elaborating and communicating scientifically-valid standards required for assessing and controlling quality of medicines and excipients.

The European Pharmacopoeial Commission is the decision-making body at the EQQM responsible elaboration and maintenance of the Ph.Eur content, including revision and updates of different monographs and general chapters.

The Ph.Eur traces its origins to 1963, when the Public Health Committee of the Council of Europe adopted a draft Convention that lay the legal, technical and administrative foundations of the Ph.Eur. The following year, the Committee of Ministers adopted the Convention and the Rules of Procedure that would govern the European Pharmacopoeia Commission.

Between 1965 and 1966, a Technical Secretariat was expanded and a Commission appointed. Three years later, the first edition of the Ph.Eur was published, and contained just over 100 monographs. Six years later in 1975, the European Union adopted Council Directive 75/318/EEC, which made compliance with Ph.Eur monographs mandatory when applying marketing authorisations.

Now in its 10th edition, the Ph.Eur as well as the Convention has 39 signatory parties from across Europe, including the European Union, that participate and vote on sessions of the European Pharmacopoeia Commission.

All these standards are designed to meet the information needs of scientists and managers involved in research and quality control of medicines, regulatory authorities and those involved in the manufacture of medicinal products or individual components.

The Ph.Eur is available as a single reference volume that covers all relevant articles featured. The 10th Edition was released in July 2019 and will be updated with eight periodic supplements over the following three years (10.1 to 10.8).

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