What is Pharmacopoeial harmonization?

PDG has provided a practical definition of harmonization; a pharmacopoeial monograph or general chapter is harmonized when a pharmaceutical substance or product tested by the document’s harmonized procedure yields the same results and the same accept/reject decision is reached.

How do you reference Ph Eur?

The official abbreviation is ‘Ph. Eur. ‘ and not ‘EP’ (which is registered for the European Parliament). A good example of a reference would be: Ph.

Is Ph Eur and BP same?

Eur. into their national pharmacopoeia; hence the British Pharmacopoeia (BP) contains the texts of the Ph. Eur.

Is USP 61 harmonized with EP?

With the advent of the harmonization, the structure of the USP and JP were altered and the two chap- ters are now USP <61> and <62>, and JP 4.05 sections I and II. The EP had a structure similar to the harmonized chapters, and those tests are still found in EP 2.6.

What do you mean by harmonization?

Harmonization means working on those areas which are complementary in order to have the plans working together for the achievement of an overall strategic objective. Harmonization helps different departments in local authorities share the same vision, work together and optimize the use of resources.

Who is International pharmacopoeia?

Int.) is a pharmacopoeia issued by the World Health Organization as a recommendation, with the aim to provide international quality specifications for pharmaceutical substances (active ingredients and excipients) and dosage forms, together with supporting general methods of analysis, for global use.

What is the purpose of reference standard?

Reference standards are used to determine quantitative data (such as assay and impurity), qualitative data (such as identification test), and calibration (such as melting point standard). Therefore, the quality and purity of the reference standards are crucial to achieve scientifically valid results.

What is EP reference standard?

Once adopted by the European Pharmacopoeia Commission, official reference standards become available for distribution. They are then used in pharmaceutical analysis, for example, for identification, purity tests or assays according to the corresponding monograph of general chapter of the European Pharmacopoeia.

What is the current EP?

The first edition of the European Pharmacopoeia was published in 1969, and consisted of 120 texts. The 10th edition, currently applicable, was published in July 2019. The Ph. Eur. is applicable in 39 European countries and used in over 100 countries worldwide.

What is British Pharmacopoeia quality?

The British Pharmacopoeia (BP) is the national pharmacopoeia of the United Kingdom. It is an annually published collection of quality standards for UK medicinal substances, which is used by individuals and organisations involved in pharmaceutical research, development, manufacture and testing.

Is USP 85 harmonized with EP?

5.2. 3 United States Pharmacopeia (USP): Text for <85> Bacterial Endotoxins Test, USP 33 Reissue (published April 2010 and official October 1, 2010). This test is harmonized with the European Pharmacopoeia and the U. S. Pharmacopeia.

What is the harmonisation status of the Ph.Eur?

PH. EUR. HARMONISATION STATUS FOR GENERAL TEXTS (as of 31 January 2021) Particle-size distribution estimation by analytical sieving (2.9.38) Preparations for inhalation: aerodynamic assessment of fine particles (2.9.18)

When do EP and USP publish a harmonized statement?

When a harmonized text has become official in all three pharmacopeias, EP and USP publish a statement indicating the harmonization status of the text; JP publishes a statement to the same effect at Stage 6B. These statements are intended to promote regulatory acceptance of interchangeability of harmonized monographs and general chapters.

How to check the harmonisation status of an excipient?

The following table summarises the sign-off coversheets for all monographs of excipients under the Pharmacopoeial Discussion Group (PDG) work plan. These coversheets provide detailed helpful information about harmonised parts and local requirements for all individual texts having undergone harmonisation by the PDG.

What are the general chapters in Pharmacopeial harmonization?

This general information chapter provides information about the concept of harmonization by the Pharmacopeial Discussion Group (PDG). The chapter provides: (1) the PDG Policy Statement;(2) the PDG Working Procedures;(3) a discussion; (4) a status report; and (5) a glossary.