Quality Systems

Proposed Legislation to Help Fight Counterfeit Drugs

Flu vaccines. Dow veterinary vaccine made in plants. $1.95 billion FDA budget focuses on high-profile programs. Non-injectable insulins win approval. FDA releases guides to dissolution testing, quality overall summary, and new drug-label formats.

Adding a cleaning step to the field-testing protocol, and combining it with the data generated to register sanitizing and disinfectant agents under FIFRA and the CEN TC 216 work program, produces a sanitation-and-disinfection validation methodology that is cost-effective, simple, and time-saving.

Madness in March: lost ingredients, missed lot numbers, and a million-dollar photo.

USP's proposed General Chapter 1226 "Verification of Compendial Procedures" aims to provide guidance about the verification process.

A new FDA policy emphasizes quality control over GMP compliance in producing clinical trial supplies.

Because of the growing popularity of single-use materials, the identification, characterization, and qualification of new materials used for disposable processes have become increasingly important for both regulatory and production purposes. This article describes one approach to identifying and validating the materials used in a disposable filling process.

Warning Letter: Southern Meds

LC–MS–MS has the potential to become a routine technique for determining drug residues in support of cleaning verification, especially early in drug development.

"It was the late 1970s," reports our GMP-Agent-in-Place, "and we used a primitive desktop computer with built-in teletype for our quality control work.

FDA is proposing revisions to the drug user fee program while it weighs changes for drug safety initiatives and expanded vaccine production.

Preliminary results from a clinical trial of Sanofi Pasteur's (Lyon, France, www.sanofi.com) H5N1 prepandemic influenza vaccine indicate the vaccine is safe and was well-tolerated in 300 healthy volunteers. This study is the first trial of an H5N1 prepandemic influenza vaccine candidate that compared vaccines with and without adjuvants.

The regulating authorities have, it seems, a preference for the application of multimembrane combinations to maximize organism retentions.

Baselines are one of the most useful tools in the 'validation toolbox'. They can be used for a variety of tasks with great success. This article will examine how they can be used and for what.

Small- and medium-sized enterprises (SMEs) will gain administrative and procedural assistance from the EMEA. The agency's SME office was launched in December 2005 and follows the new Commission Regulation, which aims to promote the development of medicinal products in SMEs.

Though dissolution testing has been under scrutiny, it is still a powerful test method.

Extractable and leachable issues should be resolved early in the drug manufacturing process. Open communication is imperative for a successful study.

Warning: Brazilian Diet Pills Found to Contain Active Drug Ingredients

Pfizer Combats Counterfeiters with RFID

FDA Issues Dispute–Resolution Guidance

Schering-Plough Meets FDA Deadline for CGMP Improvements

The benefits of zero tolerance as a test criterion have been oversold. A critical examination of zero tolerance reveals that many of the supposed benefits are not attainable. More important, inappropriate application of this criterion can have a deleterious effect on the assessment, control, and improvement of the quality of pharmaceutical products.

Repercussions from the recent courtroom problems relating to the painkiller Vioxx and patent expiration have forced Merck to take cost-cutting action. In an effort to save money, the company has closed five factories and three research institutes, and will cut 7000 jobs.

Pharmaceutical industry regulation is about to change with a new code of practice. This has been revealed by the Association of the British Pharmaceutical Industry (ABPI) following recent problems with patient safety and the dissemination of data and information of approved drugs, which exposed loopholes within the code.

Using the Bergum Method and the MS Excel software program, the author determines the probability of passing the USP dissolution test.