European Pharmacopoeia 9 Pdf
Arnaud Richardson
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 EP Colour Standards were originally visual colour standards intended to improve colour communication between sites by defining a sample colour as being close to a physical liquid standard ("near EP Y2") rather than using the words "light yellow".
The procedure for manufacturing these standards is time consuming and tedious and the stock solutions must be stored in a cool dark place in order to remain colour constant. It is for these reasons that standards of a more stable nature were in demand. Thus a series of Lovibond colour discs were originally developed to represent this scale.
An alternative to the visual methods is now available as a program in the Lovibond PFX and PFXi ranges of spectrocolorimeters. Measurements are based on specific wavelengths for each of the various pharmacopoeia colour scales (US and Chinese Pharmacopoeia are local alternatives.)
The European Pharmacopoeia (Ph.Eur.) is the legal and scientific benchmark for pharmacopoeial standards, giving binding regulations for controlling the quality of medicines and the substances used to manufacture them.
Dr. Andrea Hawe and Dr. Gerhard Sax contributed to the book of commentaries ("Arzneibuch-Kommentare") aiming to elucidate the specification given by the Ph.Eur. and to complement the chapter with comparative information. Further, supplementary references are evaluated.
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.
The European Pharmacopoeia 5.0 is supported by IRsolution Ver. 1.30 and the included validation program. The supported instruments are the IRPrestige-21 and FTIR8400S, 8300, 8400 (as of November 1, 2006). To enable support for the European Pharmacopoeia 5.0 in IRPrestige-21 and FTIR-8400S instruments already in operation, please contact your Shimadzu representative to upgrade IRsolution to Ver. 1.30.
The European Pharmacopoeia is, as the name indicates, the compilation of standards that apply to the European Union (EU).When products are shipped into the EU, they often require instrument validation complying with the European Pharmacopoeia 5.0. On the other hand, in Japan, compliance with the Japanese Pharmacopoeia is fundamental. The Japanese Pharmacopoeia is periodically revised, often with a view to linking it with the pharmacopoeia of other countries. The Japanese Pharmacopoeia infrared absorption spectrum measurement method was linked to the European Pharmacopoeia 4.0 in Revision 14, Supplement 1.With the release of the European Pharmacopoeia 5.0, differences with the Japanese Pharmacopoeia again occurred; however, it is likely that re-linking of the standard will occur in the near future with another revision. (However, as of November 1, 2006, there is no information regarding revision of the Japanese Pharmacopoeia infrared absorption spectrum measurement method.)
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