Inside Standards

A new audit guide aims to improve supply-chain security and supplier qualification practice.

Expert and implementation working groups harmonize more guidelines and move Q11 forward.

IPEC extends its reach to Brazil and Argentina in an effort to harmonize excipient best practices.

USP is working to ensure quality standards and to increase public information.

Drug manufacturers have to be more than just "audit ready."

The EDQM inspection program helps to ensure the quality of APIs on the European market.

Industry participation is crucial as USP embarks on far-reaching monograph modernization initiative. This is an online-exclusive article.

USP membership meeting prepared the standards-setting body to meet modern challenges.

Defining the Next Five Years.

Collaboration has been key to the pharmacopeia's achievement.

As drug manufacturing and standards grow, pharmacopeias must adapt to meet new challenges.

It's time to maintain a thorough traceable excipient trail.

Representatives to the PIC/S provide an example of methodology for implementing ICH Q9.

With a five-yar revision cycle around the corner, USP will hit or miss the collaboration mark.

USP workshop participants support new methods to safeguard heparin products but desire international harmonization. This article contains bonus online-exclusive material.

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

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

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.

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

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

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

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.

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

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

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

The USP public-comment process exists for a reason. Industry needs to take advantage. This article contains bonus online-exclusive material.

Attendees at a recent workshop endorsed new methods to detect metals in drugs, dietary supplements, and food ingredients.

IPEC Chairman Dave Schoneker discusses current efforts toward facilitating regulatory reviews of new excipients.

USP's guideline for pending monographs can speed up publication of monograhs and time to market.

Clear labels for substances that can be used as excipients, APIs, or both are critical to end-product use.