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European pharmacopoeia 2012 pdf

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saw the launch of the 9 Edition of the European Pharmacopeia and the The eTACT project, the EDQMs' anti-counterfeiting traceability service for. The European Pharmacopoeia and certificates of suitability (CEP). 1. European . PDG procedure: caite.info caite.info . Repartition of manufacturers (). 11 . India sites. EU Expert Working Group on the information on the Three Rs. Bruxelles, November Emmanuelle Charton. EDQM, European Pharmacopoeia.


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The Index of World Pharmacopoeias and Pharmacopoeial NFB+ caite.info . Join with caite.info Legally binding Pharmacopoeia in Switzerland: caite.info + caite.info ○ Legal basis is Swiss law European Pharmacopoeia: 1st January (caite.info ). Cover of the European Pharmacopoeia 9th edition The Ph. Eur. is applicable in The Ph. Eur. Archives contain the 1st Edition to the 8th Edition in PDF format.

Impurities may have an unwanted effect; for example, they may be toxic. Online Version: Now, the International Pharmacopoeia focuses on:. Examples of this are the insulins and somatropin monographs, published in and respectively, hepatitis B vaccine published in , interferon alfa-2 in , erythropoietin in , interferon gamma-1b in , molgramostim in , human coagulation factor VIII rDNA, insulin lispro and insulin aspart in , interferon beta-1a and filgrastim in , see Figures 1 and 2. Available in English or French. On the healthcare side, the EDQM brought forward its work on ensuring the safety and quality of blood transfusions in Europe.

European Pharmacopoeia (Ph. Eur.) 9th Edition | EDQM

A Guide for the Parents 2nd edition and Exercise your way to better post-transplant health. Commission adopted its first finished product monograph containing a chemically defined active substance and adopted its strategy for the implementation of the ICH Q3D Guideline on Elemental impurities. The Republic of Korea was granted observer status to the European Pharmacopoeia Convention and following the 5th ratification by the Republic of Guinea, the Medicrime Convention will enter into force on 01 January Resolutions on haemophilia therapies and immunoglobulin therapies for immunodeficiency and other diseases were also adopted.

Pdf european pharmacopoeia 2012

The year was an anniversary year for the EDQM. Commission published its first monograph on a chemically-defined finished product as a draft for public inquiry in Pharmeuropa and approved, together with the Committee of Experts CD-P-PH, a project for the elaboration of a pan-European formulary for non-licensed medicines for children.

European Pharmacopoeia (Ph. Eur.) 9th Edition

Azerbaijan was granted observer status to the European Pharmacopoeia Convention and Hungary and Moldova both ratified the Medicrime Convention. Recommendations defining minimum standards for haemophilia care in Europe were published and a new Standards Terms database was launched.

The 1st Edition of the Guide to the quality and safety of tissues and cells for human application was produced and several new publications on combatting counterfeit medicines and similar crimes.

Ukraine became the first country to ratify the Medicrime Convention and the 38 th Member of the European Pharmacopoeia Convention and the Republic of Guinea and Singapore received observer status. The ISO History of the EDQM to Council for europe portal. Home About us What's new? What we look for in you Employment opportunities European Pharmacopoeia What's new?

Work Programme How to participate in the work of the Ph. Join the Network!

European pharmacopoeia: Quality standards for medicines

They are mandatory requirements for manufacturers, unless otherwise stated. To give an example, the Ph. To address the complexity of the molecule, a glycan analysis was introduced in the production section together with a number of flexibility statements.

The test prescribes the use of an in-house reference preparation available only to the manufacturer.

Generic methods of analysis are prescribed, for example, the Ph. We consider that the glycan analysis approach taken in this monograph is a means of improving monograph flexibility under well-defined conditions and that it is compatible with the development of biosimilars. This same approach has recently been taken for other biotherapeutic monographs [ 8 — 10 ] to address structural complexity. At this juncture, it is important to set the record straight about the complexity of biological products argument that has been used against product-specific monographs.

CEP is used to certify that a product-specific monograph in the Ph. This possibility is not extended to biologicals because the marketing authorization holder MAH must have access to complete information concerning the production of a biological substance, without which they are unable to take responsibility for the final product.

This is not comparable to the use of a monograph and therefore has nothing to do with the issue of whether or not a monograph can or cannot address the complexity of biologicals. A second challenge is that because biologicals are complex, they display a large diversity of quality attributes, which in turn can be analysed using a large variety of methods. The authors of monographs are therefore faced with the difficulty of choosing which tests to include in the monograph.

This raises the crucial question of how the information required for a public standard should be defined. As previously stated, approved specifications form the basis for monograph elaboration.

Monographs are therefore drafted using the information submitted to EDQM by the manufacturer of the substance in question. For example, as part of the testing strategy, specific analyses may be omitted from routine testing or may be performed as in-process control tests and, therefore, are no longer included in the specifications. In addition, if the process is shown to reduce levels of specific impurities to within acceptable limits, routine testing for a specific impurity may not be performed.

As a result, further tests may be required. Sometimes, a specific quality attribute may be flagged in the Production Section. Analytical procedures are part of specifications. One real challenge is the verification of the methods before they are included in the Ph. Sometimes, the method can enter the pharmacopoeia without further work. But sometimes the methods are out-of-date or insufficiently robust.

In such cases, specific additional instructions may be needed, for example, information that was not necessarily included in a SOP Standard Operating Procedure. Sometimes the experts may recommend tightening the criteria for verification of method performance.

Pharmacopoeia pdf european 2012

When the method proposed by the manufacturer already exists in the Ph. When a monograph for a closely related substance already exists in the Ph. For certain tests, experimental verification may go beyond the monograph itself, e. In extreme cases, the decision may be taken to use an alternative method but in this event, a complete validation is required. All this work obviously requires considerable input from our expert groups and the EDQM laboratory.

Close collaboration with the manufacturer is therefore essential in order to find the best way forward for public standard setting. The EDQM is always extremely grateful to the manufacturers who have chosen to collaborate with the Ph. The reader may find it surprising that the development of biosimilars has created yet another challenge to be overcome by the groups responsible for elaborating biotherapeutic product monographs.

This is mainly due to the mistaken belief that the Ph. The following information will hopefully clarify any misunderstandings or misuse of Ph. Firstly, reference standards described in pharmacopoeial monographs and reference products necessary for the demonstration of biosimilarity are frequently confused.

Chapter 5. Secondly and most importantly, compliance to a monograph does not mean demonstration of biosimilarity. The EMA guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: The unfortunate misuse of monographs in this respect has had a negative impact on the acceptance of monographs for biotherapeutic products by some stakeholders [ 15 ].

In current debates, we should bear in mind that the Ph. On the other hand, biosimilars are a type of product that were established to avoid unnecessary repetition of preclinical and clinical studies.

The regulatory pathway to be followed is defined in appropriate guidelines. Biosimilars are developed by companies and evaluated by licensing authorities, whether or not a compendial standard exists. However, there has been some concern that monographs could actually hold up the regulatory process [ 2 ]. The EDQM totally refutes this statement: Moving on to biosimilars, 18 of the 21 biosimilar products approved in Europe are covered by a Ph. If we look at the timeline, see Figure 5 , the EMA biosimilar guidelines were established in The first biosimilar to be approved was somatropin in The first erythropoietin EPO biosimilar was approved in , and since that time, four more EPO biosimilars have been approved.

Both somatropin and EPO are covered by monographs. The EPO monograph has even been revised to accommodate the glycan distribution of one of these biosimilars. And then there is filgrastim, for which a monograph was published in The first filgrastim biosimilar was approved in and since then, seven other filgrastim biosimilars have been approved.

Since all these biosimilars have been approved, one thing is certain: If we take a closer look at the present situation, see Figure 6 , it is obvious that increasingly often, the monograph elaboration and biosimilar approval processes progress together. This is the case, for example, for insulin glargine and follitropin.

An etanercept biosimilar was approved in early At the same time, a monograph for this substance was under enquiry in Pharmeuropa [ 9 ]. The outcome of the enquiry has been very positive, with comments received from both regulatory authorities and industry: During the same period, a monograph on pegfilgrastim was published and here as well, input from industry has been extremely constructive.

The monograph itself is still being discussed as technical issues have arisen.

In the meantime, at least three pegfilgrastim biosimilars are under assessment and many biosimilar manufacturers are requesting scientific advice for their products.

This is a very strong indication that there is a pressing need for a public standard for pegfilgrastim. To summarize, it has proven possible to overcome the challenges linked to the complexity of biologicals and to elaborate biotherapeutic product monographs. However, the success of the monograph elaboration process depends on the willingness of manufacturers to provide the information and candidate reference materials required for the process.

2012 pdf pharmacopoeia european

This has proven to be more problematic since the advent of biosimilars, probably due to misunderstandings about the role of Ph. Individual monographs play a major role in ensuring that medicinal products throughout Europe meet the same quality standards, thereby contributing to patient safety. From a quality and standardization standpoint, biotherapeutic substances should not be viewed any differently from any other substance for which a monograph exists.

2012 pdf pharmacopoeia european

The EDQM wishes to warmly thank all the manufacturers who contribute to the elaboration of monographs by sharing information on the quality part of their dossiers to serve as future public standards.

The EDQM would also like to take this opportunity to draw attention to the outstanding work carried out by its experts in the complex exercise of monograph elaboration and hopes that, through debate and open dialogue, will identify how best to continue the work of standardization for biotherapeutic products. Provenance and peer review: Commissioned; internally peer reviewed. References 1.

Council of Europe. European Pharmacopoeia prepares for the future through exchange with stakeholders [homepage on the Internet].