January 2024 Drug Digest Resources List

The resources below are available to download from https://ipecamericas.org/

Current IPEC Guides

• The Joint IPEC-PQG GMP Guide for Pharmaceutical Excipients
• IPEC GMP How to Guide for Pharmaceutical Excipients
• The Joint IPEC–PQG GMP Audit Guide for Pharmaceutical Excipients
• IPEC GMP Certification Schemes & Body Qualification Guide for Pharmaceutical Excipients
• IPEC GDP Guide for Pharmaceutical Excipients
• IPEC GDP How To Guide for Pharmaceutical Excipients
• IPEC-Americas GDP Audit Guide For North American Distribution of Pharmaceutical Excipients
• The IPEC Europe GDP Audit Guideline for Pharmaceutical Excipients for Pharmaceutical Excipients
• IPEC GDP Audit Guide for Pharmaceutical Excipients
• IPEC Validation Guide for Pharmaceutical Excipients
• IPEC Certificate of Analysis Guide for Pharmaceutical Excipients
• IPEC Excipient Information Package User Guide for Pharmaceutical Excipients
• IPEC Excipient Information Package User Guide and Template, Part IV : Sustainability Overview
• IPEC Qualification of Excipients for Use in Pharmaceuticals for Pharmaceutical Excipients
• IPEC Significant Change Guide for Pharmaceutical Excipients
• IPEC Excipient Stability Program Guide

• IPEC Quality Agreement Guide and Template(s)
• IPEC Technically Unavoidable Particle Profile (TUPP) Guide
• IPEC Europe ‘How-To’ Document on EU Guidelines on Risk Assessment
• IPEC Risk Assessment Guide.Part 1 – Risk Assessment for Excipient Manufacturers
• PDA/IPEC TR No. 54-6 Formalized Risk Assessment for Excipients
• IPEC Incorporation of Pharmaceutical Excipients into Product Development using QbD Guide
• IPEC-Americas QbD Sampling Guide
• IPEC Co-Processed Excipient Guide for Pharmaceutical Excipients
• IPEC Excipient Composition Guide for Pharmaceutical Excipients
• IPEC-Americas U.S. Drug Master File Guide for Pharmaceutical Excipients
• IPEC Safety Guide for Pharmaceutical Excipients
• IPEC Americas GMP (NSF/IPEC/ANSI) Audit Guide for Pharmaceutical Excipients
• IPEC General Glossary of Terms and Acronyms

Current IPEC Position Papers

• Excipient Pedigree
• Metal Impurities in Excipients
• EU Risk Assessment Guidelines for Excipients (2015/C 95/02)
• Third Party Audit and Certification Programmes
• Supply Chain Security for Pharmaceutical Grade Excipients
• Good Manufacturing Practices for Atypical Actives
• Data Integrity for Pharmaceutical Grade Excipients
• Selecting Appropriate Excipient GMPs
• Pharmaceutical Lactose used in oral preparations is a low-risk excipient
• The Role of Excipients in Determining N-Nitrosamine - Risks for Drug Products
• Implementation of the NSF/IPEC/ANSI 363 –2014 Excipient GMP Standard
• Specifications for submitting electronic Portable Document Format (PDF) documents in support of drug registration and surveillance.
• Conducting Accelerated Stability on Excipients
• FDA Inactive Ingredient Database
• Utility of U.S. Drug Master Files (DMFs) for Excipients
• Accreditation and Certification Distinctions
• Excipient Dietary Supplement Food Additive
• Nitrosamine Considerations
for Excipient Manufacturers and Marketing Authorization Holders
• Qualifying an Excipient Manufacturing Site
• Proposal for a Directive on Falsified Medicinal Products
• EU “Guidelines of 19 March 2015 on the formalised risk assessment"
• Primary Packaging Materials (PPMs) for Pharmaceutical Excipients
• The Need for a Master File System for Novel Excipients in Europe