Quality Systems

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.

Roche Details Restructuring Plan; Sigma-Aldrich Names Successors after CEO's Death; and More.

To find out about the regulatory, formulation, and manufacturing considerations involved in developing a new device to deliver a drug, Equipment and Processing Report talked to Paul Wotton, CEO of Antares Pharma.

Normal industrial practice is to control foot-borne contamination with adhesive peel-off disposable mats, but polymeric contamination-control flooring is becoming increasingly popular.

Eli Lilly Acquires Avid Radiopharmaceuticals; EMA Recruiting New Director; and More

Pfizer (New York) announced on Oct. 29, 2010 that it intends to recall two additional lots--approximately 38,000 bottles--of Lipitor (atorvastatin calcium) 40 mg tablets distributed in the United States.

From fiscal year 2007 to 2009, the US Food and Drug Administration increased the number of foreign drug inspections it conducted, but the agency still conducted fewer foreign inspections than domestic inspections each year, according to a recent report by the US Government Accountability Office (GAO).

FDA Holds Biosimilars Public Hearing

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

IP rights and levels of innovation have opened a bit of controversy regarding decisions being made by Indian courts and legislators.