IPEC Japanは医薬品添加剤の規格及び試験方法に関する検討並びに国際調和を図るための技術交流及び情報の交換や医薬品添加剤の安全性に関する文献検索及び情報の収集、関係行政機関及び関係諸団体への連絡と協力をいたします
IPEC Japanは医薬品添加剤の規格及び試験方法に関する検討並びに国際調和を図るための技術交流及び情報の交換や医薬品添加剤の安全性に関する文献検索及び情報の収集、関係行政機関及び関係諸団体への連絡と協力をいたします
2017 IPEC Quality Agreement Guide (2017 - updated version)
The Joint IPEC-PQG Good Manufacturing Practices Guide (2017 - updated version)
IPEC Good Distribution Practices Guide (2017 - updated version)
Technically Unavoidable Particle Profile (TUPP) Guide
Significant Change Guide for Pharmaceutical Excipients
General Glossary of Terms and Acronyms
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Certificate of Analysis Guide for Bulk Pharmaceutical Excipients
Significant Change Guide for Bulk Pharmaceutical Excipients
Significant Change Guide for Bulk Pharmaceutical Excipients Third Revition 2014
FDA Guideline for Master File
CPMP CVMP Note for Guidance on Quality of water for pharmaceutical use
The IPEC Quality Agereement Guide Template
GDP (Good Distribution Practices) for Pharmaceutical Excipients
The IPEC GDP (Good Distribution Practices) Audit Guideline
GDP Guidelines on Good Distribution Practice of MedicinalProduct for Human use
Functionality-Related characteristics of Excipient
USP35(5) <1059> Excipient Performance
Standardized Excipient Information Protocol User Guide (EIP)
The IPEC Excipient Composition Guide
Volume 3B Guidelines Medicinal products for human use safety, environment and information
CHMP Guideline on Excipients in the Dossier for Application for Marketing Authorisation of a medicinal Product
Guidance for Industry Nonclinical Studies for the Safety Evaluation of Pharmaceutical Excipients
Guideline on the specification limits for residues of metal Reagents
The Safety of pharmaceutical excipients (IL FARMACO)
IPEC-Americas Novel Excipient Safety Evaluation Procedure
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