Inside Standards

Inside ICH–MHLW: Working Groups Ramp up Quality-based Implementation

September 02, 2009

Representatives of Japan's MHLW report on recent ICH activities and what the ministry expects from Q11.

Inside IPEC–Americas: Evaluating Excipient Stability

September 02, 2009

IPEC's new stability testing guide takes into account the full supply chain's storage conditions.

Inside PIC/S: South Africa's Accession to PIC/S

August 02, 2009

South Africa was the first country on the African continent to become a PIC/S member. The country's Director of Inspectorate and Law Enforcement describes the 10-year process.

Insider Solutions: Preventing the Next Heparin Scare

August 02, 2009

Determined to prevent further supply-chain breaches, industry takes charge, offers proposals.

Inside USP: Traditional Chinese Medicines and Western Regulatory Paradigms

July 02, 2009

Traditional Chinese Medicine is widely used, but questions persist regarding its regulatory status.

Inside ICH: Quality Trio Takes Final Shape

June 02, 2009

FDA leaders explain the purpose and plan for ICH's three quality guidelines.

Inside IPEC: Good Distribution Practices for Pharmaceutical Excipients

May 02, 2009

The GDP committee of IPEC–Europe is trying to seal one more broken link in the supply chain. This article contains bonus online-exclusive material.

Insider Solutions: Device Database Can Help Pharma

April 02, 2009

Standards data is helpful, but FDA needs to apply its information across the board. This article contains bonus online-exclusive material.

Inside USP: Heparin Monographs Further Revised

March 02, 2009

USP's Stage 2 heparin monograph revisions address identification, potency, and impurities.

Inside IPEC: Regulation for Excipients is Brewing Across the Atlantic

February 02, 2009

Without any GMP guidelines for excipients in Europe, change can't come soon enough for some industry groups.