EDQM - EUROPEAN DIRECTORATE FOR THE QUALITY OF MEDICINESCRS CATALOGUEHOMEABOUT USEUROPEAN PHARMACOPOEIAREFERENCE STANDARDS EDQM closure Monday 24 May 2021. Due to a public holiday in Alsace, the European Directorate for the Quality of Medicines & HealthCare (EDQM) will be closed on Monday 24 May 2021. Adoption of the revised General Notices chapter. At its 169th session (March 2021), the European Pharmacopoeia (Ph. Eur.) Commission adopted a revised version

of

EUROPEAN PHARMACOPOEIA ONLINE Terms and conditions NOTICE: by subscribing to the online version of the European Pharmacopoeia, the licensee acknowledges that he or she has read and agrees to be bound by the following General Terms and Conditions. About the European Pharmacopoeia

EDQM DATABASES

EDQM Council of Europe, 7 allée Kastner, CS 30026, F-67081 Strasbourg, France, Tel. +33 3 88 41 30 30 / Fax +33 3 88 41 27 71 REFERENCE STANDARDS OF EUROPEAN PHARMACOPOEIA PHARMEUROPA 33.2 JUST RELEASED Pharmeuropa 33.2 just released. All new European Pharmacopoeia (Ph. Eur.) texts and texts that have undergone technical revisions are published in Pharmeuropa for public consultation. The deadline for comments on Pharmeuropa 33.2 is 30 June 2021. Users and interested parties are welcome to comment on these drafts. It should be noted

that:

FOOD CONTACT MATERIALS AND ARTICLES In the field of consumer health, the EDQM helps ensure the safety of food contact materials articles in Europe, providing the secretariat of the European Committee for Food Contact Materials and Articles (CD-P-MCA).The CD-P-MCA was created to address emerging risks to human health arising from the use of food contact materials and articles, and is responsible for developing standards and

COMBISTATS | EDQM

Computer Software for the Statistical Analysis of Biological Dilution Assay Results. CombiStats TM is a computer program for the statistical analysis of data from biological dilution assays or potency assays. The software was developed at the EDQM and can perform calculations according to Chapter 5.3 of the European Pharmacopoeia (10th Edition).). The following models are inclu CERTIFICATE OF SUITABILITY (CEP): NEW APPLICATIONS Submit A New Application. To obtain a Certificate of Suitability to the monographs of the European Pharmacopoeia (CEP), applicants must send in electronic format the following documentation to the Certification of Substances Department (DCEP) of the EDQM:. a completed application form which includes your invoicing details; a dossier in CTD format written in one of the two official languages of HUMAN OCABR GUIDELINES Official Control Authority Batch Release (OCABR) for Human Biologicals: Vaccines, blood and plasma derivatives. The Guidelines for EU Official Control Authority Batch Release are now available only on the EDQM website. The website contains the most up to date versions

as listed below.

LIST OF EUROPEAN PHARMACOPOEIA (PH.EUR.) MEMBERS EDQM Council of Europe, 7 allée Kastner, CS 30026, F-67081 Strasbourg, France, Tel. +33 3 88 41 30 30 / Fax +33 3 88 41 27 71 EDQM - EUROPEAN DIRECTORATE FOR THE QUALITY OF MEDICINESCRS CATALOGUEHOMEABOUT USEUROPEAN PHARMACOPOEIAREFERENCE STANDARDS EDQM closure Monday 24 May 2021. Due to a public holiday in Alsace, the European Directorate for the Quality of Medicines & HealthCare (EDQM) will be closed on Monday 24 May 2021. Adoption of the revised General Notices chapter. At its 169th session (March 2021), the European Pharmacopoeia (Ph. Eur.) Commission adopted a revised version

of

EUROPEAN PHARMACOPOEIA ONLINE Terms and conditions NOTICE: by subscribing to the online version of the European Pharmacopoeia, the licensee acknowledges that he or she has read and agrees to be bound by the following General Terms and Conditions. About the European Pharmacopoeia

EDQM DATABASES

EDQM Council of Europe, 7 allée Kastner, CS 30026, F-67081 Strasbourg, France, Tel. +33 3 88 41 30 30 / Fax +33 3 88 41 27 71 REFERENCE STANDARDS OF EUROPEAN PHARMACOPOEIA PHARMEUROPA 33.2 JUST RELEASED Pharmeuropa 33.2 just released. All new European Pharmacopoeia (Ph. Eur.) texts and texts that have undergone technical revisions are published in Pharmeuropa for public consultation. The deadline for comments on Pharmeuropa 33.2 is 30 June 2021. Users and interested parties are welcome to comment on these drafts. It should be noted

that:

FOOD CONTACT MATERIALS AND ARTICLES In the field of consumer health, the EDQM helps ensure the safety of food contact materials articles in Europe, providing the secretariat of the European Committee for Food Contact Materials and Articles (CD-P-MCA).The CD-P-MCA was created to address emerging risks to human health arising from the use of food contact materials and articles, and is responsible for developing standards and

COMBISTATS | EDQM

Computer Software for the Statistical Analysis of Biological Dilution Assay Results. CombiStats TM is a computer program for the statistical analysis of data from biological dilution assays or potency assays. The software was developed at the EDQM and can perform calculations according to Chapter 5.3 of the European Pharmacopoeia (10th Edition).). The following models are inclu CERTIFICATE OF SUITABILITY (CEP): NEW APPLICATIONS Submit A New Application. To obtain a Certificate of Suitability to the monographs of the European Pharmacopoeia (CEP), applicants must send in electronic format the following documentation to the Certification of Substances Department (DCEP) of the EDQM:. a completed application form which includes your invoicing details; a dossier in CTD format written in one of the two official languages of HUMAN OCABR GUIDELINES Official Control Authority Batch Release (OCABR) for Human Biologicals: Vaccines, blood and plasma derivatives. The Guidelines for EU Official Control Authority Batch Release are now available only on the EDQM website. The website contains the most up to date versions

as listed below.

LIST OF EUROPEAN PHARMACOPOEIA (PH.EUR.) MEMBERS EDQM Council of Europe, 7 allée Kastner, CS 30026, F-67081 Strasbourg, France, Tel. +33 3 88 41 30 30 / Fax +33 3 88 41 27 71 REFERENCE STANDARDS OF EUROPEAN PHARMACOPOEIA Catalogue. The catalogue lists all the reference standards officially valid for the uses prescribed in the European Pharmacopoeia monographs.It is updated daily. Download the PDF format of our catalogue here.To access the most updated information about our reference standards we advise to use the online database.. Online

database

EDQM RELEASES GUIDANCE ON PAPER AND BOARD MATERIALS AND The European Directorate for the Quality of Medicines & HealthCare (EDQM) has published the first edition of the technical guide entitled “Paper and board used in food contact materials and articles”, following the October 2020 adoption of the resolution on the safety and quality of materials and articles for contact with food 1 by the Committee of Ministers of the Council of Europe. 2

EDQM STORE

Find the information you need on all EDQM publications. Ask for and print quotations for all EDQM publications. Benefit from free shipping charges by ordering online! Consult your orders including those placed via email and fax. Print relevant order documents. Consult and pay your invoices including for orders placed via email and fax. CERTIFICATE OF SUITABILITY (CEP): NEW APPLICATIONS Submit A New Application. To obtain a Certificate of Suitability to the monographs of the European Pharmacopoeia (CEP), applicants must send in electronic format the following documentation to the Certification of Substances Department (DCEP) of the EDQM:. a completed application form which includes your invoicing details; a dossier in CTD format written in one of the two official languages of GENERAL CHAPTER 2.5.42. N-NITROSAMINES IN ACTIVE In February 2021, the Ph. Eur. Commission revised the five monographs on sartans with a tetrazole ring, namely Valsartan (2423), Losartan potassium (2232), Irbesartan (2465), Candesartan cilexetil (2573) and Olmesartan medoxomil (2600), using the rapid revision process.The Production section was reworded and the N-nitrosamines test section

was deleted.

LIST OF EUROPEAN PHARMACOPOEIA (PH.EUR.) MEMBERS EDQM Council of Europe, 7 allée Kastner, CS 30026, F-67081 Strasbourg, France, Tel. +33 3 88 41 30 30 / Fax +33 3 88 41 27 71

PHARMEUROPA ONLINE

noname. Extractable elements in plastic materials for pharmaceutical use (2.4.35.); Veterinary vaccines: update of the approach to extraneous agent testing in IVMPs (implementation date 1st July 2020) - What has changed and why; Ph. Eur. Section 3. Materials for containers: clarification of legal status; Examples of validation protocols of the alternative microbiological methods according to REVISED: “VALIDATION OF COMPUTERISED SYSTEMS” GUIDELINE Since the adoption of the first version of the “Validation of Computerised Systems” guideline in May 2009, most of the Network members have introduced computerised systems e.g. Laboratory Information Management Systems (LIMS) and electronic document management systems into their labs which have become commonly used working tools of the Network. GENERAL EUROPEAN OMCL NETWORK (GEON) QUALITY … N.B. This OMCL Quality Management System document is applicable to members of the European OMCL Network only. Other laboratories might use the document on a voluntary basis.

EDQM STANDARD TERMS

EDQM Standard Terms Internal controlled vocabularies for pharmaceutical dose forms Version 1.2.0 – 28 January 2019 State of matter Basic dose form Release characteristics Transformation EDQM - EUROPEAN DIRECTORATE FOR THE QUALITY OF MEDICINESCRS CATALOGUEHOMEABOUT USEUROPEAN PHARMACOPOEIAREFERENCE STANDARDS EDQM closure Monday 24 May 2021. Due to a public holiday in Alsace, the European Directorate for the Quality of Medicines & HealthCare (EDQM) will be closed on Monday 24 May 2021. Adoption of the revised General Notices chapter. At its 169th session (March 2021), the European Pharmacopoeia (Ph. Eur.) Commission adopted a revised version

of

EUROPEAN PHARMACOPOEIA ONLINE Terms and conditions NOTICE: by subscribing to the online version of the European Pharmacopoeia, the licensee acknowledges that he or she has read and agrees to be bound by the following General Terms and Conditions. About the European Pharmacopoeia REFERENCE STANDARDS OF EUROPEAN PHARMACOPOEIA

KNOWLEDGE DATABASE

The Knowledge Database provides information on a given substance or general method of analysis and also contains information such as: the monograph’s revision history; detailed information on work on-going either for a new monograph under elaboration or for a published monograph under revision with a view to being more transparent to our users (this will also allow Ph.Eur PHARMEUROPA 33.2 JUST RELEASED Pharmeuropa 33.2 just released. All new European Pharmacopoeia (Ph. Eur.) texts and texts that have undergone technical revisions are published in Pharmeuropa for public consultation. The deadline for comments on Pharmeuropa 33.2 is 30 June 2021. Users and interested parties are welcome to comment on these drafts. It should be noted

that:

FOOD CONTACT MATERIALS AND ARTICLES In the field of consumer health, the EDQM helps ensure the safety of food contact materials articles in Europe, providing the secretariat of the European Committee for Food Contact Materials and Articles (CD-P-MCA).The CD-P-MCA was created to address emerging risks to human health arising from the use of food contact materials and articles, and is responsible for developing standards and

COMBISTATS | EDQM

Computer Software for the Statistical Analysis of Biological Dilution Assay Results. CombiStats TM is a computer program for the statistical analysis of data from biological dilution assays or potency assays. The software was developed at the EDQM and can perform calculations according to Chapter 5.3 of the European Pharmacopoeia (10th Edition).). The following models are inclu LIST OF EUROPEAN PHARMACOPOEIA (PH.EUR.) MEMBERS EDQM Council of Europe, 7 allée Kastner, CS 30026, F-67081 Strasbourg, France, Tel. +33 3 88 41 30 30 / Fax +33 3 88 41 27 71 HUMAN OCABR GUIDELINES Official Control Authority Batch Release (OCABR) for Human Biologicals: Vaccines, blood and plasma derivatives. The Guidelines for EU Official Control Authority Batch Release are now available only on the EDQM website. The website contains the most up to date versions

as listed below.

GENERAL EUROPEAN OMCL NETWORK (GEON) QUALITY … N.B. This OMCL Quality Management System document is applicable to members of the European OMCL Network only. Other laboratories might use the document on a voluntary basis. EDQM - EUROPEAN DIRECTORATE FOR THE QUALITY OF MEDICINESCRS CATALOGUEHOMEABOUT USEUROPEAN PHARMACOPOEIAREFERENCE STANDARDS EDQM closure Monday 24 May 2021. Due to a public holiday in Alsace, the European Directorate for the Quality of Medicines & HealthCare (EDQM) will be closed on Monday 24 May 2021. Adoption of the revised General Notices chapter. At its 169th session (March 2021), the European Pharmacopoeia (Ph. Eur.) Commission adopted a revised version

of

EUROPEAN PHARMACOPOEIA ONLINE Terms and conditions NOTICE: by subscribing to the online version of the European Pharmacopoeia, the licensee acknowledges that he or she has read and agrees to be bound by the following General Terms and Conditions. About the European Pharmacopoeia REFERENCE STANDARDS OF EUROPEAN PHARMACOPOEIA

KNOWLEDGE DATABASE

The Knowledge Database provides information on a given substance or general method of analysis and also contains information such as: the monograph’s revision history; detailed information on work on-going either for a new monograph under elaboration or for a published monograph under revision with a view to being more transparent to our users (this will also allow Ph.Eur PHARMEUROPA 33.2 JUST RELEASED Pharmeuropa 33.2 just released. All new European Pharmacopoeia (Ph. Eur.) texts and texts that have undergone technical revisions are published in Pharmeuropa for public consultation. The deadline for comments on Pharmeuropa 33.2 is 30 June 2021. Users and interested parties are welcome to comment on these drafts. It should be noted

that:

FOOD CONTACT MATERIALS AND ARTICLES In the field of consumer health, the EDQM helps ensure the safety of food contact materials articles in Europe, providing the secretariat of the European Committee for Food Contact Materials and Articles (CD-P-MCA).The CD-P-MCA was created to address emerging risks to human health arising from the use of food contact materials and articles, and is responsible for developing standards and

COMBISTATS | EDQM

Computer Software for the Statistical Analysis of Biological Dilution Assay Results. CombiStats TM is a computer program for the statistical analysis of data from biological dilution assays or potency assays. The software was developed at the EDQM and can perform calculations according to Chapter 5.3 of the European Pharmacopoeia (10th Edition).). The following models are inclu LIST OF EUROPEAN PHARMACOPOEIA (PH.EUR.) MEMBERS EDQM Council of Europe, 7 allée Kastner, CS 30026, F-67081 Strasbourg, France, Tel. +33 3 88 41 30 30 / Fax +33 3 88 41 27 71 HUMAN OCABR GUIDELINES Official Control Authority Batch Release (OCABR) for Human Biologicals: Vaccines, blood and plasma derivatives. The Guidelines for EU Official Control Authority Batch Release are now available only on the EDQM website. The website contains the most up to date versions

as listed below.

GENERAL EUROPEAN OMCL NETWORK (GEON) QUALITY … N.B. This OMCL Quality Management System document is applicable to members of the European OMCL Network only. Other laboratories might use the document on a voluntary basis. REFERENCE STANDARDS OF EUROPEAN PHARMACOPOEIA Catalogue. The catalogue lists all the reference standards officially valid for the uses prescribed in the European Pharmacopoeia monographs.It is updated daily. Download the PDF format of our catalogue here.To access the most updated information about our reference standards we advise to use the online database.. Online

database

EDQM DATABASES

EDQM Council of Europe, 7 allée Kastner, CS 30026, F-67081 Strasbourg, France, Tel. +33 3 88 41 30 30 / Fax +33 3 88 41 27 71 EDQM RELEASES GUIDANCE ON PAPER AND BOARD MATERIALS AND The European Directorate for the Quality of Medicines & HealthCare (EDQM) has published the first edition of the technical guide entitled “Paper and board used in food contact materials and articles”, following the October 2020 adoption of the resolution on the safety and quality of materials and articles for contact with food 1 by the Committee of Ministers of the Council of Europe. 2

EDQM STORE

Find the information you need on all EDQM publications. Ask for and print quotations for all EDQM publications. Benefit from free shipping charges by ordering online! Consult your orders including those placed via email and fax. Print relevant order documents. Consult and pay your invoices including for orders placed via email and fax. CERTIFICATE OF SUITABILITY (CEP): NEW APPLICATIONS Submit A New Application. To obtain a Certificate of Suitability to the monographs of the European Pharmacopoeia (CEP), applicants must send in electronic format the following documentation to the Certification of Substances Department (DCEP) of the EDQM:. a completed application form which includes your invoicing details; a dossier in CTD format written in one of the two official languages of QUALITY MANAGEMENT (QM) GUIDELINES Quality Management (QM) Documents. Quality Management (QM) documents have been developed for application within the General European OMCL Network. They are available to download below. They are recognised by the European co-operation for Accreditation (EA).

PHARMEUROPA ONLINE

noname. Extractable elements in plastic materials for pharmaceutical use (2.4.35.); Veterinary vaccines: update of the approach to extraneous agent testing in IVMPs (implementation date 1st July 2020) - What has changed and why; Ph. Eur. Section 3. Materials for containers: clarification of legal status; Examples of validation protocols of the alternative microbiological methods according to EDQM FAQS - FAQS HOME - FAQS Hit enter to search. Help. Online Help Keyboard Shortcuts Feed Builder

What’s new

GENERAL EUROPEAN OMCL NETWORK (GEON) QUALITY … N.B. This OMCL Quality Management System document is applicable to members of the European OMCL Network only. Other laboratories might use the document on a voluntary basis. REVISED GUIDELINE ON REQUIREMENTS FOR REVISION/RENEWAL OF Examples include the introduction of a new substantially different route of synthesis (even when the impurity profile of the final substance is equivalent), unless it replaces the current process, or the addition of a new manufacturing site of the final substance which does not belong to the same group, even when specifications are unchanged (see page 3 for a complete list of these situations). EDQM - EUROPEAN DIRECTORATE FOR THE QUALITY OF MEDICINESCRS CATALOGUEHOMEABOUT USEUROPEAN PHARMACOPOEIAREFERENCE STANDARDS EDQM closure Monday 24 May 2021. Due to a public holiday in Alsace, the European Directorate for the Quality of Medicines & HealthCare (EDQM) will be closed on Monday 24 May 2021. Adoption of the revised General Notices chapter. At its 169th session (March 2021), the European Pharmacopoeia (Ph. Eur.) Commission adopted a revised version

of

EUROPEAN PHARMACOPOEIA ONLINE Terms and conditions NOTICE: by subscribing to the online version of the European Pharmacopoeia, the licensee acknowledges that he or she has read and agrees to be bound by the following General Terms and Conditions. About the European Pharmacopoeia REFERENCE STANDARDS OF EUROPEAN PHARMACOPOEIA

KNOWLEDGE DATABASE

The Knowledge Database provides information on a given substance or general method of analysis and also contains information such as: the monograph’s revision history; detailed information on work on-going either for a new monograph under elaboration or for a published monograph under revision with a view to being more transparent to our users (this will also allow Ph.Eur PHARMEUROPA 33.2 JUST RELEASED Pharmeuropa 33.2 just released. All new European Pharmacopoeia (Ph. Eur.) texts and texts that have undergone technical revisions are published in Pharmeuropa for public consultation. The deadline for comments on Pharmeuropa 33.2 is 30 June 2021. Users and interested parties are welcome to comment on these drafts. It should be noted

that:

FOOD CONTACT MATERIALS AND ARTICLES In the field of consumer health, the EDQM helps ensure the safety of food contact materials articles in Europe, providing the secretariat of the European Committee for Food Contact Materials and Articles (CD-P-MCA).The CD-P-MCA was created to address emerging risks to human health arising from the use of food contact materials and articles, and is responsible for developing standards and

COMBISTATS | EDQM

Computer Software for the Statistical Analysis of Biological Dilution Assay Results. CombiStats TM is a computer program for the statistical analysis of data from biological dilution assays or potency assays. The software was developed at the EDQM and can perform calculations according to Chapter 5.3 of the European Pharmacopoeia (10th Edition).). The following models are inclu LIST OF EUROPEAN PHARMACOPOEIA (PH.EUR.) MEMBERS EDQM Council of Europe, 7 allée Kastner, CS 30026, F-67081 Strasbourg, France, Tel. +33 3 88 41 30 30 / Fax +33 3 88 41 27 71 HUMAN OCABR GUIDELINES Official Control Authority Batch Release (OCABR) for Human Biologicals: Vaccines, blood and plasma derivatives. The Guidelines for EU Official Control Authority Batch Release are now available only on the EDQM website. The website contains the most up to date versions

as listed below.

GENERAL EUROPEAN OMCL NETWORK (GEON) QUALITY … N.B. This OMCL Quality Management System document is applicable to members of the European OMCL Network only. Other laboratories might use the document on a voluntary basis. EDQM - EUROPEAN DIRECTORATE FOR THE QUALITY OF MEDICINESCRS CATALOGUEHOMEABOUT USEUROPEAN PHARMACOPOEIAREFERENCE STANDARDS EDQM closure Monday 24 May 2021. Due to a public holiday in Alsace, the European Directorate for the Quality of Medicines & HealthCare (EDQM) will be closed on Monday 24 May 2021. Adoption of the revised General Notices chapter. At its 169th session (March 2021), the European Pharmacopoeia (Ph. Eur.) Commission adopted a revised version

of

EUROPEAN PHARMACOPOEIA ONLINE Terms and conditions NOTICE: by subscribing to the online version of the European Pharmacopoeia, the licensee acknowledges that he or she has read and agrees to be bound by the following General Terms and Conditions. About the European Pharmacopoeia REFERENCE STANDARDS OF EUROPEAN PHARMACOPOEIA

KNOWLEDGE DATABASE

The Knowledge Database provides information on a given substance or general method of analysis and also contains information such as: the monograph’s revision history; detailed information on work on-going either for a new monograph under elaboration or for a published monograph under revision with a view to being more transparent to our users (this will also allow Ph.Eur PHARMEUROPA 33.2 JUST RELEASED Pharmeuropa 33.2 just released. All new European Pharmacopoeia (Ph. Eur.) texts and texts that have undergone technical revisions are published in Pharmeuropa for public consultation. The deadline for comments on Pharmeuropa 33.2 is 30 June 2021. Users and interested parties are welcome to comment on these drafts. It should be noted

that:

FOOD CONTACT MATERIALS AND ARTICLES In the field of consumer health, the EDQM helps ensure the safety of food contact materials articles in Europe, providing the secretariat of the European Committee for Food Contact Materials and Articles (CD-P-MCA).The CD-P-MCA was created to address emerging risks to human health arising from the use of food contact materials and articles, and is responsible for developing standards and

COMBISTATS | EDQM

Computer Software for the Statistical Analysis of Biological Dilution Assay Results. CombiStats TM is a computer program for the statistical analysis of data from biological dilution assays or potency assays. The software was developed at the EDQM and can perform calculations according to Chapter 5.3 of the European Pharmacopoeia (10th Edition).). The following models are inclu LIST OF EUROPEAN PHARMACOPOEIA (PH.EUR.) MEMBERS EDQM Council of Europe, 7 allée Kastner, CS 30026, F-67081 Strasbourg, France, Tel. +33 3 88 41 30 30 / Fax +33 3 88 41 27 71 HUMAN OCABR GUIDELINES Official Control Authority Batch Release (OCABR) for Human Biologicals: Vaccines, blood and plasma derivatives. The Guidelines for EU Official Control Authority Batch Release are now available only on the EDQM website. The website contains the most up to date versions

as listed below.

GENERAL EUROPEAN OMCL NETWORK (GEON) QUALITY … N.B. This OMCL Quality Management System document is applicable to members of the European OMCL Network only. Other laboratories might use the document on a voluntary basis. REFERENCE STANDARDS OF EUROPEAN PHARMACOPOEIA Catalogue. The catalogue lists all the reference standards officially valid for the uses prescribed in the European Pharmacopoeia monographs.It is updated daily. Download the PDF format of our catalogue here.To access the most updated information about our reference standards we advise to use the online database.. Online

database

EDQM DATABASES

EDQM Council of Europe, 7 allée Kastner, CS 30026, F-67081 Strasbourg, France, Tel. +33 3 88 41 30 30 / Fax +33 3 88 41 27 71 EDQM RELEASES GUIDANCE ON PAPER AND BOARD MATERIALS AND The European Directorate for the Quality of Medicines & HealthCare (EDQM) has published the first edition of the technical guide entitled “Paper and board used in food contact materials and articles”, following the October 2020 adoption of the resolution on the safety and quality of materials and articles for contact with food 1 by the Committee of Ministers of the Council of Europe. 2

EDQM STORE

Find the information you need on all EDQM publications. Ask for and print quotations for all EDQM publications. Benefit from free shipping charges by ordering online! Consult your orders including those placed via email and fax. Print relevant order documents. Consult and pay your invoices including for orders placed via email and fax. CERTIFICATE OF SUITABILITY (CEP): NEW APPLICATIONS Submit A New Application. To obtain a Certificate of Suitability to the monographs of the European Pharmacopoeia (CEP), applicants must send in electronic format the following documentation to the Certification of Substances Department (DCEP) of the EDQM:. a completed application form which includes your invoicing details; a dossier in CTD format written in one of the two official languages of QUALITY MANAGEMENT (QM) GUIDELINES Quality Management (QM) Documents. Quality Management (QM) documents have been developed for application within the General European OMCL Network. They are available to download below. They are recognised by the European co-operation for Accreditation (EA).

PHARMEUROPA ONLINE

noname. Extractable elements in plastic materials for pharmaceutical use (2.4.35.); Veterinary vaccines: update of the approach to extraneous agent testing in IVMPs (implementation date 1st July 2020) - What has changed and why; Ph. Eur. Section 3. Materials for containers: clarification of legal status; Examples of validation protocols of the alternative microbiological methods according to EDQM FAQS - FAQS HOME - FAQS Hit enter to search. Help. Online Help Keyboard Shortcuts Feed Builder

What’s new

GENERAL EUROPEAN OMCL NETWORK (GEON) QUALITY … N.B. This OMCL Quality Management System document is applicable to members of the European OMCL Network only. Other laboratories might use the document on a voluntary basis. REVISED GUIDELINE ON REQUIREMENTS FOR REVISION/RENEWAL OF Examples include the introduction of a new substantially different route of synthesis (even when the impurity profile of the final substance is equivalent), unless it replaces the current process, or the addition of a new manufacturing site of the final substance which does not belong to the same group, even when specifications are unchanged (see page 3 for a complete list of these situations). EDQM - EUROPEAN DIRECTORATE FOR THE QUALITY OF MEDICINESCRS CATALOGUEHOMEABOUT USEUROPEAN PHARMACOPOEIAREFERENCE STANDARDS EDQM closure Monday 24 May 2021. Due to a public holiday in Alsace, the European Directorate for the Quality of Medicines & HealthCare (EDQM) will be closed on Monday 24 May 2021. Adoption of the revised General Notices chapter. At its 169th session (March 2021), the European Pharmacopoeia (Ph. Eur.) Commission adopted a revised version

of

EDQM DATABASES

EDQM Council of Europe, 7 allée Kastner, CS 30026, F-67081 Strasbourg, France, Tel. +33 3 88 41 30 30 / Fax +33 3 88 41 27 71 EUROPEAN PHARMACOPOEIA ONLINE Terms and conditions NOTICE: by subscribing to the online version of the European Pharmacopoeia, the licensee acknowledges that he or she has read and agrees to be bound by the following General Terms and Conditions. About the European Pharmacopoeia EDQM RELEASES GUIDANCE ON PAPER AND BOARD MATERIALS AND The European Directorate for the Quality of Medicines & HealthCare (EDQM) has published the first edition of the technical guide entitled “Paper and board used in food contact materials and articles”, following the October 2020 adoption of the resolution on the safety and quality of materials and articles for contact with food 1 by the Committee of Ministers of the Council of Europe. 2 PHARMEUROPA 33.2 JUST RELEASED Pharmeuropa 33.2 just released. All new European Pharmacopoeia (Ph. Eur.) texts and texts that have undergone technical revisions are published in Pharmeuropa for public consultation. The deadline for comments on Pharmeuropa 33.2 is 30 June 2021. Users and interested parties are welcome to comment on these drafts. It should be noted

that:

GENERAL CHAPTER 2.5.42. N-NITROSAMINES IN ACTIVE In February 2021, the Ph. Eur. Commission revised the five monographs on sartans with a tetrazole ring, namely Valsartan (2423), Losartan potassium (2232), Irbesartan (2465), Candesartan cilexetil (2573) and Olmesartan medoxomil (2600), using the rapid revision process.The Production section was reworded and the N-nitrosamines test section

was deleted.

HUMAN OCABR GUIDELINES Official Control Authority Batch Release (OCABR) for Human Biologicals: Vaccines, blood and plasma derivatives. The Guidelines for EU Official Control Authority Batch Release are now available only on the EDQM website. The website contains the most up to date versions

as listed below.

EDQM STANDARD TERMSEDQM STANDARD TERMS PHARMACEUTICAL FORMEUROPEAN PHARMACOPOEIAEDQM STANDARD TERMSEMA FORM FOR MEDICAIDEUROPEAN PHARMACOPOEIA MONOGRAPHEUROPEAN PHARMACOPOEIA COA EDQM Standard Terms Internal controlled vocabularies for pharmaceutical dose forms Version 1.2.0 – 28 January 2019 State of matter Basic dose form Release characteristics Transformation

CRS RESULTS

Folic acid impurity D CRS. 4. 15 mg. 79 EUR. 30/03/2021. Y0001979. Folic acid for system suitability CRS. 2. 10 mg.

DETAILED VIEW

How to read this table. BVS Batch Validity Statement. 1- Catalogue Code designates the catalogue code that has been assigned to each Reference Standard. 2- Name lists the name of each item as designated in the European Pharmacopoeia (English version) and/or on the label. If the suffix *psy, *narc or *Drug Precursor, or MOT(biotox) appears, export authorizations are mandatory in France or EDQM - EUROPEAN DIRECTORATE FOR THE QUALITY OF MEDICINESCRS CATALOGUEHOMEABOUT USEUROPEAN PHARMACOPOEIAREFERENCE STANDARDS EDQM closure Monday 24 May 2021. Due to a public holiday in Alsace, the European Directorate for the Quality of Medicines & HealthCare (EDQM) will be closed on Monday 24 May 2021. Adoption of the revised General Notices chapter. At its 169th session (March 2021), the European Pharmacopoeia (Ph. Eur.) Commission adopted a revised version

of

EDQM DATABASES

EDQM Council of Europe, 7 allée Kastner, CS 30026, F-67081 Strasbourg, France, Tel. +33 3 88 41 30 30 / Fax +33 3 88 41 27 71 EUROPEAN PHARMACOPOEIA ONLINE Terms and conditions NOTICE: by subscribing to the online version of the European Pharmacopoeia, the licensee acknowledges that he or she has read and agrees to be bound by the following General Terms and Conditions. About the European Pharmacopoeia EDQM RELEASES GUIDANCE ON PAPER AND BOARD MATERIALS AND The European Directorate for the Quality of Medicines & HealthCare (EDQM) has published the first edition of the technical guide entitled “Paper and board used in food contact materials and articles”, following the October 2020 adoption of the resolution on the safety and quality of materials and articles for contact with food 1 by the Committee of Ministers of the Council of Europe. 2 PHARMEUROPA 33.2 JUST RELEASED Pharmeuropa 33.2 just released. All new European Pharmacopoeia (Ph. Eur.) texts and texts that have undergone technical revisions are published in Pharmeuropa for public consultation. The deadline for comments on Pharmeuropa 33.2 is 30 June 2021. Users and interested parties are welcome to comment on these drafts. It should be noted

that:

GENERAL CHAPTER 2.5.42. N-NITROSAMINES IN ACTIVE In February 2021, the Ph. Eur. Commission revised the five monographs on sartans with a tetrazole ring, namely Valsartan (2423), Losartan potassium (2232), Irbesartan (2465), Candesartan cilexetil (2573) and Olmesartan medoxomil (2600), using the rapid revision process.The Production section was reworded and the N-nitrosamines test section

was deleted.

HUMAN OCABR GUIDELINES Official Control Authority Batch Release (OCABR) for Human Biologicals: Vaccines, blood and plasma derivatives. The Guidelines for EU Official Control Authority Batch Release are now available only on the EDQM website. The website contains the most up to date versions

as listed below.

EDQM STANDARD TERMSEDQM STANDARD TERMS PHARMACEUTICAL FORMEUROPEAN PHARMACOPOEIAEDQM STANDARD TERMSEMA FORM FOR MEDICAIDEUROPEAN PHARMACOPOEIA MONOGRAPHEUROPEAN PHARMACOPOEIA COA EDQM Standard Terms Internal controlled vocabularies for pharmaceutical dose forms Version 1.2.0 – 28 January 2019 State of matter Basic dose form Release characteristics Transformation

CRS RESULTS

Folic acid impurity D CRS. 4. 15 mg. 79 EUR. 30/03/2021. Y0001979. Folic acid for system suitability CRS. 2. 10 mg.

DETAILED VIEW

How to read this table. BVS Batch Validity Statement. 1- Catalogue Code designates the catalogue code that has been assigned to each Reference Standard. 2- Name lists the name of each item as designated in the European Pharmacopoeia (English version) and/or on the label. If the suffix *psy, *narc or *Drug Precursor, or MOT(biotox) appears, export authorizations are mandatory in France or REFERENCE STANDARDS OF EUROPEAN PHARMACOPOEIA The catalogue lists all the reference standards officially valid for the uses prescribed in the European Pharmacopoeia monographs. It is updated daily. Download the PDF format of our catalogue here. To access the most updated information about our reference standards we

KNOWLEDGE DATABASE

The Knowledge Database provides information on a given substance or general method of analysis and also contains information such as: the monograph’s revision history; detailed information on work on-going either for a new monograph under elaboration or for a published monograph under revision with a view to being more transparent to our users (this will also allow Ph.Eur BLOOD TRANSFUSION GUIDE The Guide to the preparation, use and quality assurance of blood components, also known as the Blood Guide, provides a compendium of widely accepted European harmonised standards for the preparation, use and quality control of blood components to provide safety, efficacy and quality requirements for blood components in Europe and beyond.. The Blood Guide is regularly updated by the European MEMBERSHIP AND OBSERVERSHIP FOR THE EUROPEAN PHARMACOPOEIA Find out the Member ans Observer States of the European Pharmacopoeia. Membership enables states to participate in European Pharmacopoeia Commission sessions. Within these sessions, each state is represented by their national delegation consisting of not more than 3 members. On all technical matters delegations can cast a vote. The European Pharmacopoeia is a single reference HUMAN OCABR GUIDELINES Official Control Authority Batch Release (OCABR) for Human Biologicals: Vaccines, blood and plasma derivatives. The Guidelines for EU Official Control Authority Batch Release are now available only on the EDQM website. The website contains the most up to date versions

as listed below.

STANDARD TERMS

Standard Terms: Introduction and Guidance for Use – v.2.1.3 – 16 November 2018 2 1.2. Standard Terms database developments since 2014 The Standard Terms database was completely overhauled in 2014 to allow a greater flexibility in

CRS RESULTS

Folic acid impurity D CRS. 4. 15 mg. 79 EUR. 30/03/2021. Y0001979. Folic acid for system suitability CRS. 2. 10 mg. EDQM - EUROPEAN DIRECTORATE FOR THE QUALITY OF MEDICINESWEB VIEW quality overall summary. Reference: EDQM guideline PA/PH/CEP (04) 1 (as revised) Content of the dossier for chemical purity and microbiological quality

DETAILED VIEW

How to read this table. BVS Batch Validity Statement. 1- Catalogue Code designates the catalogue code that has been assigned to each Reference Standard. 2- Name lists the name of each item as designated in the European Pharmacopoeia (English version) and/or on the label. If the suffix *psy, *narc or *Drug Precursor, or MOT(biotox) appears, export authorizations are mandatory in France or

STANDARD TERMS

An updated version of the Standard Terms database was released on 21 August 2017. A new tagging feature has been added, which will allow the introduction of ‘non-traditional’ Standard Terms, i.e. terms that are not intended for use in marketing authorisation applications and labelling, but for other specific purposes such as adverse-event

reporting.

EDQM - EUROPEAN DIRECTORATE FOR THE QUALITY OF MEDICINESCRS CATALOGUEHOMEABOUT USEUROPEAN PHARMACOPOEIAREFERENCE STANDARDS EDQM closure Monday 24 May 2021. Due to a public holiday in Alsace, the European Directorate for the Quality of Medicines & HealthCare (EDQM) will be closed on Monday 24 May 2021. Adoption of the revised General Notices chapter. At its 169th session (March 2021), the European Pharmacopoeia (Ph. Eur.) Commission adopted a revised version

of

EDQM DATABASES

EDQM Council of Europe, 7 allée Kastner, CS 30026, F-67081 Strasbourg, France, Tel. +33 3 88 41 30 30 / Fax +33 3 88 41 27 71 EUROPEAN PHARMACOPOEIA ONLINE Terms and conditions NOTICE: by subscribing to the online version of the European Pharmacopoeia, the licensee acknowledges that he or she has read and agrees to be bound by the following General Terms and Conditions. About the European Pharmacopoeia EDQM RELEASES GUIDANCE ON PAPER AND BOARD MATERIALS AND The European Directorate for the Quality of Medicines & HealthCare (EDQM) has published the first edition of the technical guide entitled “Paper and board used in food contact materials and articles”, following the October 2020 adoption of the resolution on the safety and quality of materials and articles for contact with food 1 by the Committee of Ministers of the Council of Europe. 2 PHARMEUROPA 33.2 JUST RELEASED Pharmeuropa 33.2 just released. All new European Pharmacopoeia (Ph. Eur.) texts and texts that have undergone technical revisions are published in Pharmeuropa for public consultation. The deadline for comments on Pharmeuropa 33.2 is 30 June 2021. Users and interested parties are welcome to comment on these drafts. It should be noted

that:

GENERAL CHAPTER 2.5.42. N-NITROSAMINES IN ACTIVE In February 2021, the Ph. Eur. Commission revised the five monographs on sartans with a tetrazole ring, namely Valsartan (2423), Losartan potassium (2232), Irbesartan (2465), Candesartan cilexetil (2573) and Olmesartan medoxomil (2600), using the rapid revision process.The Production section was reworded and the N-nitrosamines test section

was deleted.

HUMAN OCABR GUIDELINES Official Control Authority Batch Release (OCABR) for Human Biologicals: Vaccines, blood and plasma derivatives. The Guidelines for EU Official Control Authority Batch Release are now available only on the EDQM website. The website contains the most up to date versions

as listed below.

EDQM STANDARD TERMSEDQM STANDARD TERMS PHARMACEUTICAL FORMEUROPEAN PHARMACOPOEIAEDQM STANDARD TERMSEMA FORM FOR MEDICAIDEUROPEAN PHARMACOPOEIA MONOGRAPHEUROPEAN PHARMACOPOEIA COA EDQM Standard Terms Internal controlled vocabularies for pharmaceutical dose forms Version 1.2.0 – 28 January 2019 State of matter Basic dose form Release characteristics Transformation

CRS RESULTS

Folic acid impurity D CRS. 4. 15 mg. 79 EUR. 30/03/2021. Y0001979. Folic acid for system suitability CRS. 2. 10 mg.

DETAILED VIEW

How to read this table. BVS Batch Validity Statement. 1- Catalogue Code designates the catalogue code that has been assigned to each Reference Standard. 2- Name lists the name of each item as designated in the European Pharmacopoeia (English version) and/or on the label. If the suffix *psy, *narc or *Drug Precursor, or MOT(biotox) appears, export authorizations are mandatory in France or EDQM - EUROPEAN DIRECTORATE FOR THE QUALITY OF MEDICINESCRS CATALOGUEHOMEABOUT USEUROPEAN PHARMACOPOEIAREFERENCE STANDARDS EDQM closure Monday 24 May 2021. Due to a public holiday in Alsace, the European Directorate for the Quality of Medicines & HealthCare (EDQM) will be closed on Monday 24 May 2021. Adoption of the revised General Notices chapter. At its 169th session (March 2021), the European Pharmacopoeia (Ph. Eur.) Commission adopted a revised version

of

EDQM DATABASES

EDQM Council of Europe, 7 allée Kastner, CS 30026, F-67081 Strasbourg, France, Tel. +33 3 88 41 30 30 / Fax +33 3 88 41 27 71 EUROPEAN PHARMACOPOEIA ONLINE Terms and conditions NOTICE: by subscribing to the online version of the European Pharmacopoeia, the licensee acknowledges that he or she has read and agrees to be bound by the following General Terms and Conditions. About the European Pharmacopoeia EDQM RELEASES GUIDANCE ON PAPER AND BOARD MATERIALS AND The European Directorate for the Quality of Medicines & HealthCare (EDQM) has published the first edition of the technical guide entitled “Paper and board used in food contact materials and articles”, following the October 2020 adoption of the resolution on the safety and quality of materials and articles for contact with food 1 by the Committee of Ministers of the Council of Europe. 2 PHARMEUROPA 33.2 JUST RELEASED Pharmeuropa 33.2 just released. All new European Pharmacopoeia (Ph. Eur.) texts and texts that have undergone technical revisions are published in Pharmeuropa for public consultation. The deadline for comments on Pharmeuropa 33.2 is 30 June 2021. Users and interested parties are welcome to comment on these drafts. It should be noted

that:

GENERAL CHAPTER 2.5.42. N-NITROSAMINES IN ACTIVE In February 2021, the Ph. Eur. Commission revised the five monographs on sartans with a tetrazole ring, namely Valsartan (2423), Losartan potassium (2232), Irbesartan (2465), Candesartan cilexetil (2573) and Olmesartan medoxomil (2600), using the rapid revision process.The Production section was reworded and the N-nitrosamines test section

was deleted.

HUMAN OCABR GUIDELINES Official Control Authority Batch Release (OCABR) for Human Biologicals: Vaccines, blood and plasma derivatives. The Guidelines for EU Official Control Authority Batch Release are now available only on the EDQM website. The website contains the most up to date versions

as listed below.

EDQM STANDARD TERMSEDQM STANDARD TERMS PHARMACEUTICAL FORMEUROPEAN PHARMACOPOEIAEDQM STANDARD TERMSEMA FORM FOR MEDICAIDEUROPEAN PHARMACOPOEIA MONOGRAPHEUROPEAN PHARMACOPOEIA COA EDQM Standard Terms Internal controlled vocabularies for pharmaceutical dose forms Version 1.2.0 – 28 January 2019 State of matter Basic dose form Release characteristics Transformation

CRS RESULTS

Folic acid impurity D CRS. 4. 15 mg. 79 EUR. 30/03/2021. Y0001979. Folic acid for system suitability CRS. 2. 10 mg.

DETAILED VIEW

How to read this table. BVS Batch Validity Statement. 1- Catalogue Code designates the catalogue code that has been assigned to each Reference Standard. 2- Name lists the name of each item as designated in the European Pharmacopoeia (English version) and/or on the label. If the suffix *psy, *narc or *Drug Precursor, or MOT(biotox) appears, export authorizations are mandatory in France or REFERENCE STANDARDS OF EUROPEAN PHARMACOPOEIA The catalogue lists all the reference standards officially valid for the uses prescribed in the European Pharmacopoeia monographs. It is updated daily. Download the PDF format of our catalogue here. To access the most updated information about our reference standards we

KNOWLEDGE DATABASE

The Knowledge Database provides information on a given substance or general method of analysis and also contains information such as: the monograph’s revision history; detailed information on work on-going either for a new monograph under elaboration or for a published monograph under revision with a view to being more transparent to our users (this will also allow Ph.Eur BLOOD TRANSFUSION GUIDE The Guide to the preparation, use and quality assurance of blood components, also known as the Blood Guide, provides a compendium of widely accepted European harmonised standards for the preparation, use and quality control of blood components to provide safety, efficacy and quality requirements for blood components in Europe and beyond.. The Blood Guide is regularly updated by the European MEMBERSHIP AND OBSERVERSHIP FOR THE EUROPEAN PHARMACOPOEIA Find out the Member ans Observer States of the European Pharmacopoeia. Membership enables states to participate in European Pharmacopoeia Commission sessions. Within these sessions, each state is represented by their national delegation consisting of not more than 3 members. On all technical matters delegations can cast a vote. The European Pharmacopoeia is a single reference HUMAN OCABR GUIDELINES Official Control Authority Batch Release (OCABR) for Human Biologicals: Vaccines, blood and plasma derivatives. The Guidelines for EU Official Control Authority Batch Release are now available only on the EDQM website. The website contains the most up to date versions

as listed below.

STANDARD TERMS

Standard Terms: Introduction and Guidance for Use – v.2.1.3 – 16 November 2018 2 1.2. Standard Terms database developments since 2014 The Standard Terms database was completely overhauled in 2014 to allow a greater flexibility in

CRS RESULTS

Folic acid impurity D CRS. 4. 15 mg. 79 EUR. 30/03/2021. Y0001979. Folic acid for system suitability CRS. 2. 10 mg. EDQM - EUROPEAN DIRECTORATE FOR THE QUALITY OF MEDICINESWEB VIEW quality overall summary. Reference: EDQM guideline PA/PH/CEP (04) 1 (as revised) Content of the dossier for chemical purity and microbiological quality

DETAILED VIEW

How to read this table. BVS Batch Validity Statement. 1- Catalogue Code designates the catalogue code that has been assigned to each Reference Standard. 2- Name lists the name of each item as designated in the European Pharmacopoeia (English version) and/or on the label. If the suffix *psy, *narc or *Drug Precursor, or MOT(biotox) appears, export authorizations are mandatory in France or

STANDARD TERMS

An updated version of the Standard Terms database was released on 21 August 2017. A new tagging feature has been added, which will allow the introduction of ‘non-traditional’ Standard Terms, i.e. terms that are not intended for use in marketing authorisation applications and labelling, but for other specific purposes such as adverse-event

reporting.

EDQM - EUROPEAN DIRECTORATE FOR THE QUALITY OF MEDICINESCRS CATALOGUEHOMEABOUT USEUROPEAN PHARMACOPOEIAREFERENCE STANDARDS EDQM closure Monday 24 May 2021. Due to a public holiday in Alsace, the European Directorate for the Quality of Medicines & HealthCare (EDQM) will be closed on Monday 24 May 2021. Adoption of the revised General Notices chapter. At its 169th session (March 2021), the European Pharmacopoeia (Ph. Eur.) Commission adopted a revised version

of

EDQM DATABASES

EDQM Council of Europe, 7 allée Kastner, CS 30026, F-67081 Strasbourg, France, Tel. +33 3 88 41 30 30 / Fax +33 3 88 41 27 71 EUROPEAN PHARMACOPOEIA ONLINE Terms and conditions NOTICE: by subscribing to the online version of the European Pharmacopoeia, the licensee acknowledges that he or she has read and agrees to be bound by the following General Terms and Conditions. About the European Pharmacopoeia EDQM RELEASES GUIDANCE ON PAPER AND BOARD MATERIALS AND The European Directorate for the Quality of Medicines & HealthCare (EDQM) has published the first edition of the technical guide entitled “Paper and board used in food contact materials and articles”, following the October 2020 adoption of the resolution on the safety and quality of materials and articles for contact with food 1 by the Committee of Ministers of the Council of Europe. 2 PHARMEUROPA 33.2 JUST RELEASED Pharmeuropa 33.2 just released. All new European Pharmacopoeia (Ph. Eur.) texts and texts that have undergone technical revisions are published in Pharmeuropa for public consultation. The deadline for comments on Pharmeuropa 33.2 is 30 June 2021. Users and interested parties are welcome to comment on these drafts. It should be noted

that:

GENERAL CHAPTER 2.5.42. N-NITROSAMINES IN ACTIVE In February 2021, the Ph. Eur. Commission revised the five monographs on sartans with a tetrazole ring, namely Valsartan (2423), Losartan potassium (2232), Irbesartan (2465), Candesartan cilexetil (2573) and Olmesartan medoxomil (2600), using the rapid revision process.The Production section was reworded and the N-nitrosamines test section

was deleted.

HUMAN OCABR GUIDELINES Official Control Authority Batch Release (OCABR) for Human Biologicals: Vaccines, blood and plasma derivatives. The Guidelines for EU Official Control Authority Batch Release are now available only on the EDQM website. The website contains the most up to date versions

as listed below.

EDQM STANDARD TERMSEDQM STANDARD TERMS PHARMACEUTICAL FORMEUROPEAN PHARMACOPOEIAEDQM STANDARD TERMSEMA FORM FOR MEDICAIDEUROPEAN PHARMACOPOEIA MONOGRAPHEUROPEAN PHARMACOPOEIA COA EDQM Standard Terms Internal controlled vocabularies for pharmaceutical dose forms Version 1.2.0 – 28 January 2019 State of matter Basic dose form Release characteristics Transformation

CRS RESULTS

Folic acid impurity D CRS. 4. 15 mg. 79 EUR. 30/03/2021. Y0001979. Folic acid for system suitability CRS. 2. 10 mg.

DETAILED VIEW

How to read this table. BVS Batch Validity Statement. 1- Catalogue Code designates the catalogue code that has been assigned to each Reference Standard. 2- Name lists the name of each item as designated in the European Pharmacopoeia (English version) and/or on the label. If the suffix *psy, *narc or *Drug Precursor, or MOT(biotox) appears, export authorizations are mandatory in France or EDQM - EUROPEAN DIRECTORATE FOR THE QUALITY OF MEDICINESCRS CATALOGUEHOMEABOUT USEUROPEAN PHARMACOPOEIAREFERENCE STANDARDS EDQM closure Monday 24 May 2021. Due to a public holiday in Alsace, the European Directorate for the Quality of Medicines & HealthCare (EDQM) will be closed on Monday 24 May 2021. Adoption of the revised General Notices chapter. At its 169th session (March 2021), the European Pharmacopoeia (Ph. Eur.) Commission adopted a revised version

of

EDQM DATABASES

EDQM Council of Europe, 7 allée Kastner, CS 30026, F-67081 Strasbourg, France, Tel. +33 3 88 41 30 30 / Fax +33 3 88 41 27 71 EUROPEAN PHARMACOPOEIA ONLINE Terms and conditions NOTICE: by subscribing to the online version of the European Pharmacopoeia, the licensee acknowledges that he or she has read and agrees to be bound by the following General Terms and Conditions. About the European Pharmacopoeia EDQM RELEASES GUIDANCE ON PAPER AND BOARD MATERIALS AND The European Directorate for the Quality of Medicines & HealthCare (EDQM) has published the first edition of the technical guide entitled “Paper and board used in food contact materials and articles”, following the October 2020 adoption of the resolution on the safety and quality of materials and articles for contact with food 1 by the Committee of Ministers of the Council of Europe. 2 PHARMEUROPA 33.2 JUST RELEASED Pharmeuropa 33.2 just released. All new European Pharmacopoeia (Ph. Eur.) texts and texts that have undergone technical revisions are published in Pharmeuropa for public consultation. The deadline for comments on Pharmeuropa 33.2 is 30 June 2021. Users and interested parties are welcome to comment on these drafts. It should be noted

that:

GENERAL CHAPTER 2.5.42. N-NITROSAMINES IN ACTIVE In February 2021, the Ph. Eur. Commission revised the five monographs on sartans with a tetrazole ring, namely Valsartan (2423), Losartan potassium (2232), Irbesartan (2465), Candesartan cilexetil (2573) and Olmesartan medoxomil (2600), using the rapid revision process.The Production section was reworded and the N-nitrosamines test section

was deleted.

HUMAN OCABR GUIDELINES Official Control Authority Batch Release (OCABR) for Human Biologicals: Vaccines, blood and plasma derivatives. The Guidelines for EU Official Control Authority Batch Release are now available only on the EDQM website. The website contains the most up to date versions

as listed below.

EDQM STANDARD TERMSEDQM STANDARD TERMS PHARMACEUTICAL FORMEUROPEAN PHARMACOPOEIAEDQM STANDARD TERMSEMA FORM FOR MEDICAIDEUROPEAN PHARMACOPOEIA MONOGRAPHEUROPEAN PHARMACOPOEIA COA EDQM Standard Terms Internal controlled vocabularies for pharmaceutical dose forms Version 1.2.0 – 28 January 2019 State of matter Basic dose form Release characteristics Transformation

CRS RESULTS

Folic acid impurity D CRS. 4. 15 mg. 79 EUR. 30/03/2021. Y0001979. Folic acid for system suitability CRS. 2. 10 mg.

DETAILED VIEW

How to read this table. BVS Batch Validity Statement. 1- Catalogue Code designates the catalogue code that has been assigned to each Reference Standard. 2- Name lists the name of each item as designated in the European Pharmacopoeia (English version) and/or on the label. If the suffix *psy, *narc or *Drug Precursor, or MOT(biotox) appears, export authorizations are mandatory in France or REFERENCE STANDARDS OF EUROPEAN PHARMACOPOEIA The catalogue lists all the reference standards officially valid for the uses prescribed in the European Pharmacopoeia monographs. It is updated daily. Download the PDF format of our catalogue here. To access the most updated information about our reference standards we

KNOWLEDGE DATABASE

The Knowledge Database provides information on a given substance or general method of analysis and also contains information such as: the monograph’s revision history; detailed information on work on-going either for a new monograph under elaboration or for a published monograph under revision with a view to being more transparent to our users (this will also allow Ph.Eur BLOOD TRANSFUSION GUIDE The Guide to the preparation, use and quality assurance of blood components, also known as the Blood Guide, provides a compendium of widely accepted European harmonised standards for the preparation, use and quality control of blood components to provide safety, efficacy and quality requirements for blood components in Europe and beyond.. The Blood Guide is regularly updated by the European MEMBERSHIP AND OBSERVERSHIP FOR THE EUROPEAN PHARMACOPOEIA Find out the Member ans Observer States of the European Pharmacopoeia. Membership enables states to participate in European Pharmacopoeia Commission sessions. Within these sessions, each state is represented by their national delegation consisting of not more than 3 members. On all technical matters delegations can cast a vote. The European Pharmacopoeia is a single reference HUMAN OCABR GUIDELINES Official Control Authority Batch Release (OCABR) for Human Biologicals: Vaccines, blood and plasma derivatives. The Guidelines for EU Official Control Authority Batch Release are now available only on the EDQM website. The website contains the most up to date versions

as listed below.

STANDARD TERMS

Standard Terms: Introduction and Guidance for Use – v.2.1.3 – 16 November 2018 2 1.2. Standard Terms database developments since 2014 The Standard Terms database was completely overhauled in 2014 to allow a greater flexibility in

CRS RESULTS

Folic acid impurity D CRS. 4. 15 mg. 79 EUR. 30/03/2021. Y0001979. Folic acid for system suitability CRS. 2. 10 mg. EDQM - EUROPEAN DIRECTORATE FOR THE QUALITY OF MEDICINESWEB VIEW quality overall summary. Reference: EDQM guideline PA/PH/CEP (04) 1 (as revised) Content of the dossier for chemical purity and microbiological quality

DETAILED VIEW

How to read this table. BVS Batch Validity Statement. 1- Catalogue Code designates the catalogue code that has been assigned to each Reference Standard. 2- Name lists the name of each item as designated in the European Pharmacopoeia (English version) and/or on the label. If the suffix *psy, *narc or *Drug Precursor, or MOT(biotox) appears, export authorizations are mandatory in France or

STANDARD TERMS

An updated version of the Standard Terms database was released on 21 August 2017. A new tagging feature has been added, which will allow the introduction of ‘non-traditional’ Standard Terms, i.e. terms that are not intended for use in marketing authorisation applications and labelling, but for other specific purposes such as adverse-event

reporting.

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2 new reference standards and 20 replacement batches released in May

2021

Reference Standard / Collection & Catalogue News 04 June 2021

Strasbourg, France

The EDQM announces the availability of 2 new European Pharmacopoeia (Ph. Eur.) reference standards and 20 replacement batches for Ph. Eur. reference standards. twitter facebook googleplus pinterest

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New general chapter on Cell-based assay for potency determination of TNF-alpha antagonists (2.7.26) published for public enquiry European Pharmacopoeia / Monograph News 02 June 2021 Strasbourg,

France

The European Pharmacopoeia (Ph. Eur.) is seeking stakeholder feedback on the new proposed draft chapter on Cell-based assay for potency determination of TNF-alpha antagonists (2.7.26) published in this quarter’s issue of Pharmeuropa (33.2), for comment. twitter facebook googleplus pinterest

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2.9.19. Particulate contamination: sub-visible particles – PDG revision of general chapter released for public consultation European Pharmacopoeia / Pharmacopoeial harmonisation News 20 May 2021

Strasbourg, France

A new, revised version of general chapter 2.9.19. Particulate contamination: sub-visible particles has been published in Pharmeuropa

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Adoption of the revised General Notices chapter At its 169th session (March 2021), the European Pharmacopoeia (Ph. Eur.) Commission adopted a revised version of chapter 1. General

Notices.

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7 new reference standards and 26 replacement batches released in... The EDQM announces the availability of: 7 new European Pharmacopoeia (Ph. Eur.) reference standards and 26 replacement batches for Ph. Eur. reference standards. twitter facebook googleplus pinterest

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Certification monthly report of activities: April 2021 The latest monthly activity report for the Certification of Substances Department (DCEP) is now available.

See all news

AGENDA

16 June 2021

Strasbourg, France

Webinar on the Council of Europe Resolution on good recon... 28 June 2021 to 09 July 2021

Strasbourg, France

NEW! EDQM Virtual Training Programme: independent modules... 05 October 2021 to 07 October 2021

Strasbourg, France

NEW: FREE CombiStats™ Webinar Training Sessions

See all events

See Reference standards Catalogue Ph. Eur. 10th Edition presentation Reference Standards & publication store Free Publications and Databases Certification of Suitability (CEP) News Have a question? FAQ & HelpDesk https://www.edqm.eu/en/edqms-response-nitrosamine-contamination Nitrosamine contamination

In brief

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Since _N_-nitrosamines, possible carcinogens for humans, were detected in 2018 in a number of active substances, the EDQM has been working with regulatory authorities to ensure that no medicinal products containing nitrosamine contaminants reach the end user. This has involved, among others, REVIEWING CERTIFICATES OF SUITABILITY (used in marketing authorisation applications), REVISING EUROPEAN PHARMACOPOEIA MONOGRAPHS for the active substances concerned and ESTABLISHING NEW REFERENCE STANDARDS to support the implementation of the new Ph. Eur. general chapter on the analysis of _N_-nitrosamines. The EDQM OMCL Network has also co-ordinated the DEVELOPMENT OF TESTING PROCEDURES that ensure adequate control of impurities and a risk-based sampling and testing programme. https://www.edqm.eu/en/news/all The Vision of the EDQM

In brief

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* A Directorate of the Council of Europe created in 1964. * A leading organisation that protects public health by enabling the development, supporting the implementation and monitoring the application of quality standards for safe medicines and their safe

use.

* Also develops guidance and standards in the areas of blood transfusion, organ transplantation and consumer health issues. https://www.edqm.eu/en/news/european-pharmacopoeia The European Pharmacopoeia

In brief

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* Main objective is to provide common quality standards to control the quality of medicines and of substances used in the manufacture of medicines (human and veterinary use). * Legally binding in European member states. * 39 signatory parties (including the EU) and 30 observers (including WHO and TFDA) as of March 2018. https://www.edqm.eu/en/news/omcl-network Official Medicines Control Laboratories (OMCL)

In brief

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* A network of independent public laboratories appointed by the national authorities. * Around 70 laboratories provide human and technical resources to implement testing programmes. * 36 European countries and 5 countries outside Europe participate in the various activities and programmes. https://www.edqm.eu/en/news/certification-of-suitability The Certification of Suitability

In brief

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* Established in 1994. * Over 4,900 certificates covering more than 1,100 substances have been granted in more than 60 countries. * Assessment is jointly performed by a network of around 100 assessors from the national competent authorities and EDQM assessors. * Organises an inspection programme involving a network of around 30 inspectors from 20 different national competent authorities and the

EDQM.

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COVID-19 pandemic

Focus

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The EDQM’s core activities include the provision of documentary and physical (reference) standards to ensure the quality of medicines and their ingredients. Availability of and access for patients to quality medicines is more important than ever in the context of the current COVID-19 pandemic. This is why the EDQM is working hard to ensure the continuous supply of our goods and services and is engaging with all stakeholders, including national, European and international authorities, to help protect public health. * The EDQM’s contributions to the protection of public health in the COVID-19 pandemic: latest information * EDQM business continuity plan to safeguard core activities * EDQM initiatives in the context of COVID-19 vaccines and therapies

HOW TO ORDER

Via our web store at store.edqm.eu in order to benefit from free handling charges (on publications only). Alternatively, you can send your order to the EDQM Sales section by: * post: EDQM – Council of Europe, 7 allée Kastner, CS 30026, 67081 Strasbourg, France * e-mail: orders@edqm.eu Invoices can be paid by credit card via internet or by bank transfer. @EDQM_NEWS ON TWITTER

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