Quality Systems

The authors relay the outcome of a two-day workshop that brought together regulators and generic-drug industry representatives.

Industry, equipment vendors, and regulators are busy refining the precision and reliability of dissolution testing.

BIO supports recent Congressional action toward a 12-year data exclusivity period for innovators.

Like life, the workplace also can have many surprises.

FDA has been encouraging drug sponsors to use a systematic approach such as quality-by-design principles for pharmaceutical development.

Representatives of one pilot program participant, Wyeth, outline the experiences and lessons learned for implementing a science- and risk-based approach to drug-development and manufacturing.

The author discusses control strategies via near infrared instrumentation for continuous mixing, granulation, drying, and extrusion with a more focused detail on mixing.

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

The EMEA intends to fully implement its Product Information Management (PIM) approach, an initiative designed to improve information management, into the centralized procedure within 2 years, according to a statement of intent from the agency.

A review of NIPTE's core projects and its plans for training-and retraining-the pharmaceutical industry.

The FDA issued a proposed rule to clarify the cGMP requirements applicable to combination products in the Federal Register.

This article introduces the "Q.U.E.S.T." approach for vendor qualification, a practical and compliant methodology for pharmaceutical and biopharmaceutical companies to qualify vendors and hence make well-informed purchasing-related decisions.

As the pharmaceutical industry moves further into Central and Eastern Europe and the Commonwealth of Independent States, several standard-setting and regulatory bodies are also increasing collaboration in the region, particularly in Russia.

The author describes the framework needed to implement QbD and achieve the deeper process understanding that is fundamental to QbD.

Pharmaceutical companies get ideas for sustainable packaging from other industries.

The author analyzes, from an agency perspective, whether question-based review has improved product quality or made the review process easier for regulators or for industry.

Jeff Robertson talks about a unique form of micro-tag technology that can be applied to solid dose pharmaceuticals.

Also, FDA bans candy and fruit-flavored cigarettes, EMEA moves to improve information management.

The US Food and Drug Administration issued a proposed rule to clarify the current good manufacturing practice (CGMP) requirements applicable to combination products in the Sept. 23 Federal Register.

On September 25, the European Medicines Agency's (EMEA) Committee for Medicinal Products for Human Use (CHMP) recommended the authorization of two vaccines for use in Europe against the H1N1 influenza: GlaxoSmithKline's (GSK) Pandemrix and Novartis's Focetria.

The FDA has sent Bayer Schering Pharma (Germany) a Warning Letter, citing deviations from cGMP in the manufacture of nonsterile APIs.

The US Food and Drug Administration plans to hold a public hearing to discuss the promotion of agency-regulated drugs and medical devices on the Internet and using social media tools, according to a notice in the Sept. 21, 2009, Federal Register.

Also, FDA extended the deadline for the pilot program for the submission of CMC information.

The US Food and Drug Administration sent Bayer Schering Pharma (Berlin) a Warning Letter on Aug. 5, 2009, citing deviations from current good manufacturing practice in the manufacture of nonsterile active pharmaceutical ingredients (APIs).

Product failure can be potentially fatal to a customer and have severe implications for manufacturers; however, many pharma companies still believe that complaint management is not related to the overall management of customer relationships.