Quality Systems

Process designs and control strategies can be improved by adopting a risk-based approach to product quality. The author describes how this approach can be applied to spray-drying operations.

US Food and Drug Administration leaders issued another cry for help last week. Center for Drug Evaluation and Research Director Janet Woodcock testified before the Senate Health, Education, Labor and Pensions (HELP) committee at an April 24 hearing, "Restoring FDA's Ability to Keep America's Families Safe."

Problems associated with contamination of heparin products continue after worldwide recalls in March in the United States, Italy, France, and Denmark.

Researchers from the Georgia Institute of Technology described a fast method to detect counterfeit "Tamiflu," Roche's drug for preventing and treating bird flu.

The United States Pharmacopeial Convention (USP) has agreed to work with the US Food and Drug Administration on developing more sensitive tests for detecting contaminants such as over-sulfated chondroitin, which was found in batches of heparin last January.

The US House of Representatives Energy and Commerce Committee is proposing legislation to address the funding and authority of the US Food and Drug Administration in regulating the safety of the country's drug supply.

The US Food and Drug Administration issued a draft guidance to clarify the Agency's intensions stated in the Food and Drug Administration Amendments Act of 2007 (FDAAA) requiring sponsors, industry, researchers, and investigators to complete certification form FDA Form 3674 when submitting documentation to the Agency in order to comply with FDAAA, Title VIII.

The US Food and Drug Administration issued a final guidance last week regarding investigational new drug applications for human gene therapy.

A manufacturing line can be improved if technology transfer is implemented thoughtfully. Effective technology transfer helps to provide process efficiency and control and maintain product quality.

MannKind suspended discussions with potential partners for the commercialization of its "Technosphere Insulin" product.

Also, Alcon plans to open Singapore facility, Pharmacopeia president and CEO retired, more...

In an ongoing effort to secure the safety of prescription drugs, the US Food and Drug Administration has released its draft five-year plan under the Prescription Drug User Fee Act (PDUFA).

Senator Chuck Grassley (R-IA) sent a letter to Amgen (Thousand Oaks, CA) last week asking the company to account for the high rebates it has given to certain physician groups who bought Aranesp.

The US Food and Drug Administration withdrew a direct final rule that changed current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. The agency withdrew the rule because it received significant adverse comments from industry.

The deadline for the implementation of California's prescription drug tracking system, ePedigree, has been delayed until January 2011.

At its annual meeting, the Pharmaceutical Research and Manufacturers of America elected Richard T. Clark, CEO and president of Merck & Co., chairman of its board.

Also, VaxGen and Raven terminate merger agreement, Darren Head appointed CEO of Cytovance, more...

Filing risk and mitigation strategies is now a requirement for manufacturers of new drugs and biologics.

A reference book omits important information and ignores advanced testing procedures.

Essential components of a good inspection: good ingredients, proper inserts, and ... deer?

The FDA itself issues a cry for help. Is anybody listening?

Sophisticated replication techniques have made counterfeiting and fraud a serious threat to the pharmaceutical industry.

Regulatory agencies expect companies to establish and monitor clean equipment- and dirty equipment-hold times for manufacturing equipment as part of their cleaning validation program.

Was FDA's decision to issue a draft guidance on of-label information, amidst Congressional scrutiny, the right thing to do?

Undertaking process validation involves a major commitment in terms of personnel, resources, time, and money. Performing prerequisite verifications can reduce the risk of making costly mistakes. This Part 1 article explains the value of performing prerequisite verifications and presents case-study examples and real-world solutions to avoid costly process validation failures.

Heparin contamination casts a shadow on regulatory oversight of product quality.

Brief pharmaceutical news items for April 2008.

Manufacturing facilities must be inspected by members of regulatory bodies. However… these bodies are woefully inadequate at performing the task.

US Representatives Anna G. Eshoo (D-CA) and Joe Barton (R-TX) introduced legislation this month week to create a regulatory pathway for biosimilars, or follow-on biologics.

Also, Alkermes announces restructuring and reduction of workforce, Icagen announces several senior management promotions, more...