日本医薬品添加剤協会

**ガイドラインリスト**
IPEC Qualification of Excipients for Use in Pharmaceuticals 「医薬品添加剤の必要要件ガイド」	Phase1 添加剤製造業者プロセス（製造管理）
	Phase1 添加剤製造業者プロセス（開発）
	Phase2 医薬品製造業者プロセス
	Phase3 交渉プロセス

Phase1 添加剤製造業者プロセス（製造管理）	Phase1に関係する他のガイドライン
	Certificate of Analysis Guide for Bulk Pharmaceutical Excipients
	Significant Change Guide for Bulk Pharmaceutical Excipients
	FDA Guideline for Master File
	CPMP CVMP Note for Guidance on Quality of water for pharmaceutical use

Phase1 添加剤製造業者プロセス (開発）	Phase1に関係する他のガイドライン
	The IPEC Quality Agereement Guide and Template
	GDP (Good Distribution Practices) for Pharmaceutical Excipients
	The IPEC GDP (Good Distribution Practices) Audit Guideline GDP Audit attachment
	GDP Guidelines on Good Distribution Practice of Medicinal Product for Human use
	Fuctionality-Related characteristics of Excipient
	USP35(5)　<1059>　Excipient Performance
	Standardized Excipient Information Protocol User Guide (EIP)

Phase2 医薬品製造業者プロセス	Phase2に関係する他のガイドライン
	The IPEC Excipient Composition Guide
	EudraLex Vol.3B Guidelines Human
	CHMP Guideline on Excipients in the Dossier for Application for Marketing Authorisation of a medicinal Product

GMP自主基準に関するガイドライン	Good Manufacturing Practices for bulk pharmaceutical Excipients
	The Joint IPEC-PQG Good Manufacturing Practices Audit Guideline 2008

安全性に関するガイドライン	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)
	Excipient biological Safety Evaluation Guideline
	Guidance for Industry Nonclinical studies for the safety evaluation of pharmaceutical excipients
	Stimuli to the revision process (Pharmacopeial Forum – Excipient Performance)
	IPEC-Americas Novel Excipient Safety Evaluation Procedure

その他のガイドライン	Regulatory Toxicology and Parmacology, A perspective on testing of existing pharmaceutical excipients for genotoxic impurities
	CHMP Scientific Article 5(3) opinion on the potential risks
	CHMP for Human use, Guidelines on the limits of genotoxic impurities

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