Updated: IPEC Questionnaire for Excipient Nitrosamines Risk Evaluation
Category: IPEC FederationIPEC Federation announces the availability of the updated “Questionnaire for Excipient Nitrosamines Risk Evaluation” (version 2).
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IPEC Federation Connect 2-2025
Category: IPEC FederationIn this issue: updates from the latest publications, our participation in events and workshops, and news from the regional IPECs.
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IPEC Federation statement on the ‘WHO–UNODC Report on Contaminated Medicines and Integrity of the Pharmaceutical Excipients Supply Chain’
Category: IPEC FederationStatement on the ‘WHO–UNODC Report on Contaminated Medicines and Integrity of the Pharmaceutical Excipients Supply Chain’
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Updated: IPEC Federation Position on Pharmaceutical Excipients GMP Documents
Category: IPEC FederationA position paper that explains the various excipient GMP guides and standards supported by IPEC Federation.
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Now available: IPEC Risk Assessment Guide
Category: IPEC FederationIPEC Federation announces the availability of the IPEC Risk Assessment Guide for Pharmaceutical Excipients – Risk Assessment for Excipient Manufacturers.
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IPEC Federation Connect 1/2025
Category: IPEC FederationIn this edition, we present the priority objectives for this year and regional updates from our five regional IPEC members.
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Updated: IPEC Quality-by-Design Guide
Category: IPEC FederationIPEC Federation announces the availability of the updated IPEC Incorporation of Pharmaceutical Excipients into Product Development using Quality-by-Design (QbD) (Version 2, 2025).
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IPEC Federation Position Paper on Third Party Audit and Certification Programmes
Category: IPEC FederationIPEC Federation announces the availability of an updated position paper on Third Party Audit and Certification Programmes
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IPEC Federation Connect 2/2024
Category: IPEC FederationIn this edition, we provide you with updates from the latest publications, our participation to events and workshops, and news from the regional IPECs.
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Updated: IPEC Good Distribution Practices (GDP) Guide
Category: IPEC FederationIPEC Federation announces the availability of the updated IPEC Good Distribution Practices (GDP) for Pharmaceutical Excipients.
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Insights from the Lhasa Limited and IPEC Europe Nitrites collaborative meeting
Category: IPEC EuropeRead the report of the first face-to-face Nitrites meeting held in March 2024.
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IPEC Federation Connect 1/2024
Category: IPEC FederationWelcome to our first 2024 issue of the IPEC Federation bulletin, which we hope you will find interesting. In this edition, we delve into the priority objectives for 2024 and regional updates.
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Interview with The Medicine Maker – Keep Your Eye on the Supply
Category: IPEC FederationThe Medicine Maker hosted an interview with Dr. Frank Milek to highlight the importance of ensuring security of the excipient supply chain in light of the recent incidents caused by DEG contamination in different areas of the world.
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Updated: IPEC Position Paper on Role of Excipients in Determining N-Nitrosamine Risks for Drug Products
Category: IPEC FederationIPEC 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)
Category: IPEC FederationIPEC 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
Category: IPEC FederationIPEC 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
Category: IPEC FederationIPEC Federation announces the availability of the revised and updated IPEC General Glossary of Terms and Acronyms for Pharmaceutical Excipients.
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IPEC Federation Position Paper on Supply Chain Security
Category: IPEC FederationIPEC 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
Category: IPEC FederationWelcome 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
Category: IPEC FederationIPEC 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
Category: IPEC FederationIPEC 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
Category: IPEC FederationIPEC 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
Category: IPEC FederationIPEC 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
Category: IPEC FederationIPEC 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
Category: IPEC FederationIPEC 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
Category: IPEC EuropePlease complete a quick survey on Certificates of Suitability by 11 May 2022.
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IPEC Federation Connect - 1/2022
Category: IPEC FederationWelcome 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
Category: IPEC FederationThis 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
Category: IPEC EuropeIPEC 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
Category: IPEC FederationIPEC Federation announces the availability of the new IPEC Safety Guide for Pharmaceutical Excipients.
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Updated IPEC Guide: GDP Audit Guide for Pharmaceutical Excipients
Category: IPEC FederationIPEC 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
Category: IPEC FederationWelcome 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
Category: IPEC FederationIPEC 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
Category: IPEC EuropeIPEC 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
Category: IPEC EuropeIPEC 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
Category: IPEC EuropeNovel 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
Category: IPEC FederationThis 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
Category: IPEC EuropeIPEC 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
Category: IPEC FederationIPEC 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
Category: IPEC FederationIPEC 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
Category: IPEC FederationIPEC 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
Category: IPEC FederationIPEC 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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IPEC Federation position on Pharmaceutical Excipients GMP Documents
Category: IPEC FederationA 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
Category: IPEC FederationIPEC 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
Category: IPEC FederationIPEC Federation is pleased to announce the revised IPEC Excipient Composition Guide.
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IPEC Federation announces the revised IPEC Excipient Information Package Guide
Category: IPEC FederationIPEC Federation announces the availability of the revised IPEC Excipient Information Package - User Guide and Templates (EIP).
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Procedure for audit postponement and remote audits of pharmaceutical excipient suppliers
Category: EXCiPACTEXCiPACT 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”
Category: IPEC FederationWelcome 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
Category: IPEC FederationPDA and IPEC Federation announce the joint publication of Technical Report No. 54-6 - Formalized Risk Assessment for Excipients.
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IPEC Federation position on Supply Chain Security
Category: IPEC FederationIPEC 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
Category: IPEC EuropeIPEC 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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