Quality Systems

New product reviews for February 2012.

FDA and industry expert working group representatives discuss the pending ICH Q11 guideline.

ICH Q8, Q9, and Q10 support and implications for the future.

The author describes an equation that can be used to define the Quality relationship between a contract manufacturing organization and a client, including how to factor in both party's needs and regulatory commitments.

The US Pharmacopeia announced a draft standard containing best practices for ensuring that drugs can be traced to their original manufacturer, are not counterfeited or adulterated, and can be transported to their intended destination without compromising quality.

USP Releases Guidelines on Ensuring the Integrity of the Pharmaceutical Supply Chain.

The FDA has released a new draft guidance that offers recommendations to companies wishing to respond to unsolicited requests for off-label information, including requests made via social media websites.

The authors designed an upper punch with a removable punch tip to determine a tablet formulation's propensity to stick by weighing the mass of powder adhered to the punch tip.

The benefits of harmonization may be on industry's wish list, but buying into change is another story.

Pressure to approve new user fees opens the door to action on drug shortages, prices, and regulation.

As part of the BRIC bloc with Russia, India, and China, Brazil is one of the world's leading emerging economies and is also considered by IMS Health to be one of seven pharmerging nations, which also include Mexico, Turkey, and South Korea.

Technology may expedite operations, but the absence of the human element could cost dearly.

To keep moving forward, the Pharmacopoeial Discussion Group needs industry participation.

The European Union market takes steps toward continuous processing and modular facilities.

Copay coupons may help patients and drugmakers, but who ends up holding the bag?

The author describes how providing appropriate information about the API in the Common Technical Document can aid FDA's review of an abbreviated new drug application.

A Q&A with Gilles Cottier, president of SAFC, on recent industry trends.

New product reviews for January 2012.

Multilayer tablets can be challenging, but meeting regulatory expectations is crucial. We speak with Vilayat Sayeed from the FDA, to find out more about the critical factors that need to be fully understood.

Risk assessment is not a new concept to the pharmaceutical industry, but lately the phrase has become a mantra. A systemic, science-based way to manage risk is becoming essential to meeting the spirit and letter of FDA requirements.

In a Warning Letter, FDA cited "significant violations" of CGMP regulations, including several repeat observations, at three Novartis facilities located in Colorado, North Carolina, and Canada.

The FDA and EMA are moving from "confidence-building to reliance upon" each other in a step-up in cooperation on GMP inspections; the latest move following successful completion of pilot projects this summer.

Cultivating a productive investment environment will require partnerships with a range of stakeholders.

Cleanliness is crucial, even if zapping and trapping is necessary to reduce product contamination.

The seventh in a series of eight case studies from the Product Quality Research Institute focuses on packout remedies.

Added responsibilities and outside concerns prompt overhaul of agency's structure.

Contract organizations must have highly organized teams and plans to accommodate today's audits.

Drug shortages, supply-chain security, generic-drug incursion, and flexible manufacturing models are some of the issues shaping the bio/pharma industry.

Precedents set in the historic Barr case continue to raise questions over suitable sample-size criteria.

Political leaders need to consider the impact of the biopharmaceutical industry on the economy.