January 2024 Drug Digest Resources List

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Article

Below is a list of IPEC Guides and Position Papers that are available as FREE downloads from the IPEC-Americas website.

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
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