Inside Standards - Pharmaceutical Technology

Latest Issue
PharmTech

Latest Issue
PharmTech Europe

Inside Standards

Securing the Supply Chain

July 2, 2014

Pharmaceutical Technology

Regulators and industry leaders take on the task of securing the drug supply chain.

Large Industry Cross-Section Contributes to PDA Quality Metrics Recommendations

February 2, 2014

Pharmaceutical Technology

PDA works with FDA to create pharmaceutical quality metrics.

Deficiencies Found in API Inspections

December 2, 2013

Pharmaceutical Technology

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

Control of Elemental Impurities

November 2, 2013

Pharmaceutical Technology

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

USP Partners Globally for 21st-Century Medicines

July 2, 2013

Pharmaceutical Technology

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

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

April 2, 2013

Pharmaceutical Technology

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.

The Need for Pharmacopeial Harmonization

April 2, 2013

Pharmaceutical Technology

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

Moisture Permeation of Pharmaceutical Packaging

April 2, 2013

Pharmaceutical Technology

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

Conforming to the IPEC CoA Guide

March 2, 2013

Pharmaceutical Technology

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

ADVERTISEMENT

LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
|Monthly
| Weekly

Survey
FDASIA was signed into law two years ago. Where has the most progress been made in implementation?
Reducing drug shortages
Breakthrough designations
Protecting the supply chain
Expedited reviews of drug submissions
More stakeholder involvement
Reducing drug shortages
70%
Breakthrough designations
4%
Protecting the supply chain
17%
Expedited reviews of drug submissions
2%
More stakeholder involvement
7%
View Results
Eric Langerr Outsourcing Outlook Eric LangerTargeting Different Off-Shore Destinations
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerAsymmetric Synthesis Continues to Advance
Jill Wechsler Regulatory Watch Jill Wechsler Data Integrity Key to GMP Compliance
Sean Milmo European Regulatory WatchSean MilmoExtending the Scope of Pharmacovigilance Comes at a Price
Click here