Topic

Carmelo Rosa is chair of the PIC/S API Expert Circle and director, Division of International Drug Quality, US FDA.

Paula R. Katz, acting branch chief for Regulatory Policy and Collaboration, US FDA, CDER/Office of Compliance/Office of Manufacturing and Product Quality.

Alicia Mozzachio, branch chief, Division of International Drug Quality, US FDA, CDER/Office of Compliance/Office of Manufacturing and Product Quality.

Articles

PIC/S reviews deficiencies found during inspections of API manufacturing facilities, harmonizes GMP standards, and provides training for inspectors worldwide.

Deficiencies Found in API Inspections

Susanne Keitel, MD, is head of the European Directorate for the Quality of Medicines of the Council of Europe. EDQM is responsible for the European Pharmacopoeia.

The European Pharmacopoeia Commission has decided to change its approach on elemental impurities.

Control of Elemental Impurities

Desmond G. Hunt is principal scientific liaison, USP Department of Science, General Chapters.

USP seeks input from stakeholders on new and revised standards to mitigate extractables and leachables in plastic packaging systems.

USP Seeks Input on Standards for Plastic Packaging Systems

USP focuses on building worldwide partnerships in standards-setting activities.

USP Partners Globally for 21st-Century Medicines

Shireesh P. Apte, PhD, is a lead scientist at Baxter I.V. Systems Inc.

This article summarizes the development and modernization of the United States Pharmacopeia-National Formulary (USP-NF) fixed-oil excipient monographs. This article contains bonus online-exclusive material.

Fixed-Oil Excipient Monographs: Development of USP Fixed-Oil Reference Standards

USP is proposing a new performance testing standard for moisture permeation of pharmaceutical packaging.

Moisture Permeation of Pharmaceutical Packaging

In the context of international trade, the need to develop global quality standards for medicines is increasing.

The Need for Pharmacopeial Harmonization

Past IPEC-Americas excipient qualification committee chairs highlight changes to the IPEC guide on certificates of analysis for bulk excipients.

Conforming to the IPEC CoA Guide

The US Pharmacopeial Convention contiues to make modernization of standards a top priority in 2013.

Modernization of USP Standards

Antonio Hernandez-Cardoso, MSc, is senior scientific liaison with the US Pharmacopeial Convention (USP).

Kahkashan Zaidi, PhD,* is a senior scientist in the Department of Standards Development; at the US Pharmacopeia, 12601 Twinbrook Parkway, Rockville, MD 20852-1790, tel. 301.816.8269, kxz@usp.org

Maura C. Kibbey is director of science and standards, USP Global Biologics.

USP's focus in 2013 involves standards relating to organic impurities, measurement of residual DNA and host-cell proteins in biotechnology products, and elemental impurities.

Inside Standards