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Updated: IPEC Position Paper on Role of Excipients in Determining N-Nitrosamine Risks for Drug Products

  • 27 Feb 2024
Category: IPEC Federation

IPEC Federation announces the availability of the updated IPEC Position Paper on “The Role of Excipients in Determining N-Nitrosamine Risks for Drug Products”.

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Updated: IPEC Quality Agreement Guide and Template(s)

  • 21 Feb 2024
Category: IPEC Federation

IPEC Federation announces the availability of the revised and updated IPEC Quality Agreement Guide and Template(s) for Pharmaceutical Excipients.

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Updated: IPEC Technically Unavoidable Particle Profile (TUPP) Guide

  • 5 Feb 2024
Category: IPEC Federation

IPEC Federation announces the availability of the revised and updated IPEC TUPP Guide for Pharmaceutical Excipients.

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Updated: IPEC Glossary of Terms and Acronyms

  • 14 Dec 2023
Category: IPEC Federation

IPEC Federation announces the availability of the revised and updated IPEC General Glossary of Terms and Acronyms for Pharmaceutical Excipients.

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Internship - Events and Admin assistant

  • 6 Dec 2023
Category: IPEC Europe

Are you looking for an internship in administrative and event support? Join a dynamic not-for-profit association representing pharmaceutical excipients!

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IPEC Federation Position Paper on Supply Chain Security

  • 30 Aug 2023
Category: IPEC Federation

IPEC Federation announces the availability of an updated position paper, “Latest fatal incidents with contaminated medicinal syrup during 2022/2023”.

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IPEC Federation Connect - 1/2023

  • 17 Jul 2023
Category: IPEC Federation

Welcome to our first 2023 issue of the IPEC Federation bulletin, which we hope you will find interesting. In this edition, we delve into the priority objectives for 2023 and regional updates.

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Now available: Excipient Information Package User Guide and Template, Part IV: Sustainability

  • 8 Mar 2023
Category: IPEC Federation

IPEC Federation announces the availability of the new Excipient Information Package User Guide and Template, Part IV: Sustainability.

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Updated: IPEC Significant Change Guide for Pharmaceutical Excipients

  • 28 Feb 2023
Category: IPEC Federation

IPEC Federation announces the availability of the updated IPEC Significant Change Guide for Pharmaceutical Excipients (Version 5, 2023)

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IPEC Questionnaire for Excipient Nitrosamines Risk Evaluation

  • 21 Feb 2023
Category: IPEC Federation

IPEC Federation announces the availability of its “Questionnaire for Excipient Nitrosamines Risk Evaluation” (version 1).

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Updated: IPEC Excipient Stability Guide for Pharmaceutical Excipients

  • 17 Nov 2022
Category: IPEC Federation

IPEC Federation announces the availability of the updated IPEC Stability Guide for Pharmaceutical Excipients (Version 2, 2022)

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Updated: IPEC Certificate of Analysis Guide

  • 3 Nov 2022
Category: IPEC Federation

IPEC Federation announces the availability of the updated IPEC Certificate of Analysis Guide for Pharmaceutical Excipients (Version 2, 2022).

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Updated: IPEC-PQG Good Manufacturing Practices Guide for Pharmaceutical Excipients

  • 26 Sep 2022
Category: IPEC Federation

IPEC Federation and the Pharmaceutical Quality Group (PQG) are pleased to announce the availability of the revised IPEC-PQG Good Manufacturing Practices Guide for Pharmaceutical Excipients (version 5).

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Survey - Certificates of Suitability

  • 4 May 2022
Category: IPEC Europe

Please complete a quick survey on Certificates of Suitability by 11 May 2022.

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IPEC Federation Connect - 1/2022

  • 29 Mar 2022
Category: IPEC Federation

Welcome to the latest edition of the IPEC Federation bulletin. In this edition, we delve into the Federation’s objectives for 2022 and the recent meeting with PDG.

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IPEC Federation position on The Role of Excipients in Determining N-Nitrosamine Risks for Drug Products

  • 1 Mar 2022
Category: IPEC Federation

This position paper describes IPEC Federation’s position on the role of excipients when conducting N-nitrosamine (nitrosamine) risk assessments for drug products

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Best Practices document: Multicompendial Compliance Strategy

  • 17 Nov 2021
Category: IPEC Europe

IPEC Europe is pleased to announce the availability of a Best Practices document, “Executing a Multicompendial Compliance Strategy for Pharmaceutical Excipients”

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New IPEC Guide: Safety Guide for Pharmaceutical Excipients

  • 4 Nov 2021
Category: IPEC Federation

IPEC Federation announces the availability of the new IPEC Safety Guide for Pharmaceutical Excipients.

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Developments in global pharmaceutical excipients in the next 3–5 years

  • 4 Oct 2021
Category: Stakeholders

An interesting article sets the key theme that will shape the excipient landscape in the near future such as regulations, innovation, economics and sustainability.

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Updated IPEC Guide: GDP Audit Guide for Pharmaceutical Excipients

  • 14 Sep 2021
Category: IPEC Federation

IPEC Federation announces the availability of the revised IPEC Good Distribution Practices Audit Guide for Pharmaceutical Excipients (Version 3, 2021).

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IPEC Federation Connect: new issue

  • 22 Jul 2021
Category: IPEC Federation

Welcome to the latest edition of the IPEC Federation bulletin, which we hope you will find interesting. In this edition, we delve into the Federation’s objectives for 2021 and news from the IPECs around the world.

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Spanish version of the IPEC GDP Guide now available

  • 25 May 2021
Category: IPEC Federation

IPEC Federation announces the availability of the Spanish version of the IPEC Good Distribution Practices Guide for Pharmaceutical Excipients (version 2, 2017).

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CPhI article on the importance of Excipients

  • 28 Apr 2021
Category: IPEC Europe

IPEC Europe and EFCG continue to make the case that the importance of novel excipients needs to be fully recognised and are pleased to see that others are beginning to take notice too.

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Updated: Questionnaire for Excipient Nitrosamines Risk Evaluation

  • 15 Mar 2021
Category: IPEC Europe

IPEC Europe announces the availability of its revised “Questionnaire for Excipient Nitrosamines Risk Evaluation” (version 3).

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Position Paper: Innovative Medicines need Novel Excipients

  • 15 Mar 2021
Category: IPEC Europe

Novel excipients are essential for the development of new medicines and vaccines. Read the joint IPEC Europe-EFCG position paper.

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IPEC Federation position on Pharmaceutical Lactose used in oral preparations

  • 1 Mar 2021
Category: IPEC Federation

This position paper describes IPEC Federation’s position on the risk classification of lactose in all oral preparations.

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Updated: IPEC Glossary of Terms and Acronyms

  • 10 Feb 2021
Category: IPEC Europe

IPEC Federation announces the availability of the updated IPEC Glossary. To consult it online, click here

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New IPEC Guide: Validation Guide for Pharmaceutical Excipients

  • 13 Jan 2021
Category: IPEC Federation

IPEC Federation announces the availability of the new International Pharmaceutical Excipients Council Validation Guide for Pharmaceutical Excipients.

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Updated IPEC guide: Qualification of Excipients for Use in Pharmaceuticals

  • 15 Dec 2020
Category: IPEC Federation

IPEC Federation announces the availability of the revised IPEC Qualification of Excipients for Use in Pharmaceuticals Guide and Checklist.

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New IPEC Guide: GMP Certification Scheme and Certification Body Qualification Guide For Pharmaceutical Excipients

  • 12 Nov 2020
Category: IPEC Federation

IPEC Federation announces the availability of the new International Pharmaceutical Excipients Council GMP Certification Scheme and Certification Body Qualification Guide for Pharmaceutical Excipients.

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New IPEC Guide: Incorporation of Pharmaceutical Excipients into Product Development using Quality-by-Design

  • 3 Nov 2020
Category: IPEC Federation

IPEC Federation announces the availability of a new guide: Incorporation of Pharmaceutical Excipients into Product Development using Quality-by-Design (QbD guide).

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Infographic: The Pharmaceutical supply chain in Europe

  • 20 Aug 2020
Category: IPEC Europe

IPEC Europe, EFCG and APIC address the complex pharmaceutical supply chain in Europe in a joint infographic.

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Survey - Novel excipients: why don't we use them?

  • 10 Jul 2020
Category: IPEC Europe

Are you a drug formulator? Help us build the case for novel excipients in Europe and complete the survey by 31 August!

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IPEC Federation position on Pharmaceutical Excipients GMP Documents

  • 29 Jun 2020
Category: IPEC Federation

A position paper that explains the various excipient GMP guides and standards currently available has been published by the IPEC Federation.

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Position paper on Data Integrity for Pharmaceutical Grade Excipients

  • 30 Apr 2020
Category: IPEC Federation

IPEC Federation announces the availability of a new position paper on Data Integrity for Pharmaceutical Grade Excipients.

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IPEC Federation revises its Excipient Composition Guide

  • 23 Apr 2020
Category: IPEC Federation

IPEC Federation is pleased to announce the revised IPEC Excipient Composition Guide (Version 2, 2020).

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IPEC Federation announces the revised IPEC Excipient Information Package Guide

  • 22 Apr 2020
Category: IPEC Federation

IPEC Federation announces the availability of the revised IPEC Excipient Information Package - User Guide and Templates (EIP) (Version 4, 2020).

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Procedure for audit postponement and remote audits of pharmaceutical excipient suppliers

  • 7 Apr 2020
Category: EXCiPACT

EXCiPACT issued a new procedure for audit postponement and the use of remote audits of pharmaceutical excipients suppliers.

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IPEC Federation publishes first issue of “IPEC Federation Connect”

  • 26 Mar 2020
Category: IPEC Federation

Welcome to the first edition of the IPEC Federation Connect, a bulletin providing a periodic round-up of what the IPEC Federation and other IPECs have been up to!

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PDA and IPEC Federation Publish Technical Report No. 54-6

  • 17 Dec 2019
Category: IPEC Federation

PDA and IPEC Federation announce the joint publication of Technical Report No. 54-6 - Formalized Risk Assessment for Excipients.

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Questionnaire for Excipient Nitrosamines Risk Evaluation

  • 5 Dec 2019
Category: IPEC Europe

IPEC Europe developed a questionnaire in consultation with other pharmaceutical-related associations (including EFPIA) to facilitate gathering information on pharmaceutical excipients for drug product manufacturers to perform nitrosamine risk evaluations.

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IPEC Federation position on Supply Chain Security

  • 23 May 2019
Category: IPEC Federation

IPEC Federation publishes its position paper on supply chain security for Pharmaceutical Grade Excipients.

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The case for an Excipient Master File in Europe

  • 15 May 2019
Category: IPEC Europe

IPEC Europe released a position paper and a Stimuli article to highlight how the absence of an Excipient Master File system in Europe is a barrier to the introduction of novel excipients and to innovation in the healthcare sector.

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