Pharmaceutical Technology-08-02-2005

August 02, 2005

Stability data that do not follow the expected trend in comparison with other stability batches or previous results collected during a stability study are considered out-of-trend (OOT) results. OOT stability results recently have gained the attention of regulatory agencies and as a result, the approach for identifying and investigating OOT results has become a topic of increased discussion. One example is a 2003 article by the PhRMA Chemistry, Manufacturing, and Controls Statistics and Stability Expert Teams, which was intended to initiate dialogue on how to address OOT results (1).

August 02, 2005

Chiron Corporation (Emeryville, CA, www.chiron.com) announced that quality problems at its Marlburg, Germany, manufacturing plant will prevent the company from supplying its "Begrivac" influenza virus vaccine to non-US markets for the 2005–2006 flu season.

August 02, 2005

As one Midwestern city has discovered, there is life after Big Pharma.

August 02, 2005

The pharmaceutical outsourcing industry is well into its second year of very strong growth, and indications appear that it will enjoy a healthy third year as well.

August 02, 2005

Cyclone Commerce's (Scottsdale, AZ, www.cyclonecommerce.com) "Cylone ePedigree" system helps combat counterfeit drugs by tracking the authenticity and origin of a given drug as it moves through the supply chain.

August 02, 2005

Although new drug development usually focuses on clinical and preclinical research, moving innovative products from clinical testing to market mainly involves overcoming manufacturing capabilities and production challenges. Ensuring access to consistently high-quality critical vaccines and therapies needed to counter bioterrorism attacks is a topic frequently debated. Product shortages are leading to policies that expand US drug and vaccine manufacturing and ensure that US regulatory and healthcare policies avoid erecting roadblocks to high-quality drug production.

August 02, 2005

Our GMP Agent-in-Place at a top-10 pharmaceutical manufacturing firm reports on a spill during the manufacture of a time-release capsule filled with coated beads.

August 02, 2005

In 1987, when the US Food and Drug Administration issued its Guideline on General Principles of Process Validation, a young FDA reviewer asked her supervisors.

August 02, 2005

Solid dosage form manufacturers have long relied on shape and color as well as on-pill imprints of logos, product names, or numbers for product identification. But in these days of heightened counterfeiting concerns, the industry has a growing interest in adding more difficult-to-duplicate features to the pool of existing product identification techniques. Added security is particularly important on high-profile or high-cost drugs, as well as on pharmaceutical products supplied in bulk for repackaging.

August 02, 2005

Being the first to gain the most is a fundamental principle in the generics business because several companies compete to create generics of successful products going off patent. For a generics company to maintain revenue growth in a market in which product prices continue to fall, it must secure a continuous flow of new products, with quality and speed to market being key drivers. Thus, generics companies must be highly skilled in product and process development (1), the generics business, and achieving bioequivalence-the most critical development area.