Quality Systems

The threat of counterfeit medicines in the next year will be more severe than ever, according to a survey of 1000 companies conducted in October 2010 by Pharma IQ.

Excipients should be regulated to manage risk. Although, excipients are an integral part of a finished pharmaceutical product, the issue of regulation is complex.

GlaxoSmithKline (GSK) issued a statement on Jan. 2, 2011, to respond to a 60 Minutes segment that aired on Jan. 2 that focused on quality-control problems at a former GSK manufacturing facility in Cidra, Puerto Rico.

Gilead Sciences to Acquire Arresto Biosciences; Sartorius Appoints Head of Lab Business; and More.

John Taylor to Serve as Acting Principal Deputy Commissioner after Joshua Sharfstein's Departure, and more.

US Senator Amy Klobuchar (D-MN) urged the US Food and Drug Administration and the pharmaceutical industry to address what she called an "unprecedented" shortage of prescription drugs, especially for chemotherapy.

FDA received the authority to mandate recalls of food under a new food-safety bill. Efforts are underway in the House to grant the agency this power for pharmaceuticals as well.

The European Commission and Medicines Agency seem to be moving in advance of their ICH partners to update standards.

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

The authors discuss how their research will help FDA in its identification of areas of emphasis in pre- and postapproval evaluation of products and processes.

Top priorities for manufacturers include user fees, new health initiatives, and regulatory compliance.

The authors discuss the role of quality-control automation in providing better data, enhanced compliance, and potentially faster release times.

Capable of great works, pharma as a whole still yields to the lesser angels of its nature.

Industry executives share insight into the future direction of drug manufacturing and the supply chain.

Holding product and supply-chain security to the highest standards is crucial for the future.

After five years of discussions, the US Food and Drug Administration is joining the Pharmaceutical Inspection Convention (PIC) and the Pharmaceutical Inspection Cooperation Scheme (PIC Scheme), known together as PIC/S.

The European Medicines Agency launched on December 20, 2010, a public registry about small and medium-sized enterprises (SME) that includes information about SME-registered companies.

Pfizer Recalls One Lipitor Lot; Sanofi Aventis Names Head of R&D; and More.

A US Food and Drug Administration inspection completed on Dec. 9, 2010 revealed persistent deficiencies at McNeil Consumer Healthcare's Fort Washington, Pennsylvania, facility.

Abbott Laboratories (Abbott Park, IL), B. Braun Medical (Bethlehem, PA), and Roxane Laboratories, a subsidiary of Boehringer Ingelheim (Ingelheim am Rhein, Germany), agreed to pay the United States $421 million to settle False Claims Act allegations.

Supportive public policy is needed in order for innovation to flourish.

Sometimes doing what you think is right ends up being completely and utterly wrong.

The author explains the idea of equivalence and describes how it can facilitate equipment validation.

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

A review of warning letters from the last 10 years relating specifically to cleanrooms has indicated several concerns with the appropriateness of cleanroom design - primarily regarding air flow and laminarity.

A European-wide awareness initiative hopes to tackle the issue of antibiotic over-prescription, but industry must also be encouraged to make further investments.

With the increasing need for businesses to reduce costs and demonstrate value, there is a requirement to look at all aspects of bio/pharma drug development and manufacturing to achieve efficiency improvements.

A case study describes how a software control system can manage training needs across an international company and improve GMP compliance.

The International Conference on Harmonization (ICH) Steering Committee (SC) and its working groups met in Fukuoka, Japan Nov. 6-11, 2010.

During the 20 months before the crisis of contaminated heparin in early 2008, the US Food and Drug Administration did not inspect any Chinese heparin firms, according to a US Government Accountability Office, (GAO) report.