European Pharmacopoeia Pdf Free Download
Phillipp Schneeberger
The European 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.
In FTIR Validation, we discussed validation methods for infrared spectrophotometers. We introduced the European Pharmacopoeia 4.0 as one of the standards for the infrared of spectrophotometers. Content related to infrared spectrophotometers is described in the section "2.2.24 Absorption Spectrophotometry, Infrared", and instrument validation methods are described under the items "Control of resolution performance" and "Verification of the wave-number scale".
In 2005, the European Pharmacopoeia 5.0 was introduced, and these standards were revised. In this article, we introduce the points of revision and how the Shimadzu FTIR series addresses these changes.
There was a change from the use of transmittance measurement of spectra in the European Pharmacopoeia 4.0 to the use of spectra obtained by absorbance measurement, and the resolution standard is now specified according to absorbance measurement exclusively.
The wavenumber verification criteria in European Pharmacopoeia 4.0 specified as 1.5 for the three wavenumbers 3060.0, 2849.5 and 1942.9 cm-1 was changed to an allowable variance of 1.0 in the new standard.
The validation program supporting the European Pharmacopoeia 5.0 is included in IRsolution Ver. 1.30.
In both the Japanese Pharmacopoeia and European Pharmacopoeia 4.0, instrument performance evaluation is based on the 5 test items: (1) power spectrum, (2) resolution, (3) wavenumber accuracy, (4) wavenumber repeatability and (5) absorbance reproducibility.
1. Power Spectrum
Although not included in the European Pharmacopoeia 5.0, this test is used to evaluate the most basic performance of the FTIR. The test procedure is the same in the validation program for both the Japanese Pharmacopoeia and European Pharmacopoeia 4.0. This test compares the intensity of the power spectrum at a specified wavenumber to the criterion values. When the measured intensity is equal or larger than the criterion value, the test is passed.
2. Resolution
This is as described above. A pass rating is assessed if each of the absorbance values is equal to or greater than the respective criterion value.
3. Wavenumber Accuracy
This is as described above. A pass rating is assessed if each of the wavenumber measurement values is within the specified variance.
4. Wavenumber Reproducibility
Although this test is not included in the European Pharmacopoeia 5.0, this is regarded as a test item due to standardization with the Japanese Pharmacopoeia. The test procedure is the same in the validation program for both the Japanese Pharmacopoeia and European Pharmacopoeia 4.0.
Polystyrene film is measured twice, and the peak wavenumbers are compared at three specified points. The program assesses whether or not the difference between the two measurement results is within the permissible range. If the difference in peak wavenumbers is within the permissible range at all three specified points, a pass rating is assessed.
5. Absorbance Reproducibility
Although this test is not included in the European Pharmacopoeia 5.0, this is regarded as a test item due to standardization with the Japanese Pharmacopoeia. The test procedure is the same in the validation program for both the Japanese Pharmacopoeia and European Pharmacopoeia 4.0. The permissible range according to the Japanese Pharmacopoeia is 0.5 %, expressed in transmittance; however, in the validation program that supports the European Pharmacopoeia 5.0, transmittance values that fluctuate 0.5 % from the transmittance at the test wavenumber are converted to absorbance, and are then evaluated with respect to the permissible range. For example, the absorbance of the 2849.5 cm-1 peak is about 1 ABS (about 10 % transmittance), so the absorbance fluctuation (0.03 ABS) corresponding to the 0.5 % transmittance fluctuation is considered the permissible range. Polystyrene film is measured twice, and the absorbance values are compared at three specified points. The program assesses whether or not the difference between the two measurement results is within the permissible range. If the difference in absorbances is within the permissible range at all three specified points, a pass rating is assessed.