Compendial Compliance

Resources, Guidelines, and Guidance Documents

September 15, 2019

Find links to pertinent regulatory and standard setting resources, guidance documents, and guidelines.

Regulatory and Standard Setting Organizations

September 15, 2019

Connect with pharmaceutical and healthcare regulatory authorities around the world via this directory.

Why Pharmacopoeia Compliance Is Necessary

September 15, 2019

This article provides the legal and regulatory basis for pharmacopoeia compliance and illustrates pharmacopoeia impact throughout the drug product lifecycle.

A Brief History of Pharmacopoeias: A Global Perspective

September 15, 2019

This article examines the history and evolution of the pharmacopoeias and the particular challenges that must be overcome to achieve harmonization among the pharmacopoeias.

Global Pharmacopoeia Standards: Why Harmonization is Needed

September 15, 2019

Pharmacopoeia harmonization provides better support for global regulatory agencies and addresses the global nature of bio/pharmaceutical manufacturing and supply.

Harmonization Efforts by Pharmacopoeias and Regulatory Agencies

September 15, 2019

The authors take a closer look at these ongoing efforts to harmonize compendial standards, with perspective that may be helpful in considering the future direction of pharmacopoeias.

Why Pharmacopoeia Compliance Is Difficult–An End-to-End Compendial Framework

September 15, 2019

This article provides an end-to-end compendial framework to understand why compliance with pharmacopoeia standards is challenging.

Global Pharmacopoeia Standards: Why Harmonization is Needed (PDF)

September 15, 2019

Pharmacopoeia harmonization provides better support for global regulatory agencies and addresses the global nature of bio/pharmaceutical manufacturing and supply.

Why Pharmacopoeia Compliance Is Difficult–An End-to-End Compendial Framework (PDF)

September 15, 2019

This article provides an end-to-end compendial framework to understand why compliance with pharmacopoeia standards is challenging.

Why Pharmacopoeia Compliance Is Necessary (PDF)

September 15, 2019

This article provides the legal and regulatory basis for pharmacopoeia compliance and illustrates pharmacopoeia impact throughout the drug product lifecycle.