Regulatory/GMP Compliance, Emerging Markets

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.

FDA Expands Scope of API Impurity Investigation

August 29, 2019

While downgrading the impact of nitrosamine impurities on patients, FDA vows to step up investigations for other drug types.

Is it Time to Update cGMPs?

July 02, 2019

Industry practice has changed radically over the past five decades. Can laws published in the 1960s still ensure pharmaceutical quality and safety today?

ICH Approves Four New Regulatory Observers and Reviews Progress of Harmonization Efforts

June 19, 2019

During its biannual meeting in Amsterdam, ICH approved four new regulatory observers and reviewed the progress made on global harmonization efforts.

Pharma Facilities Still Have a Lot to Learn

June 02, 2019

FDA’s annual manufacturing report card shows more quality compliance is needed.

Supply Chain Risk and Security Maturity Evolution

June 02, 2019

Discussing supply chain risk and security as a business led journey, Roddy Martin, chief digital strategist at TraceLink, explains the five stages of its evolution.