Regulatory/GMP Compliance

Characterizing the higher order structure (HOS) of protein drugs increases manufacturers' understanding of stability and batch-to-batch variability, and may make it possible to link variants or aggregates to safety and efficacy. Yet at the January 24 CMC Strategy Forum in Washington, DC, regulators expressed concern that methods to characterize the three-dimensional structure of proteins are not routinely applied to biotechnology products.

An effective CAPA plan provides a mechanism for responding to the unexpected.

The new Sentinel system aims to expand access to data on medical product safety and patient effects.

Trouble at Genzyme and with flu vaccine production illustrates the challenges in producing safe and potent biologics.

One might look at QbD's plodding growth and conclude that it is never going to make it to graduation.

How will implementing Quality by Design strategies affect your compliance status?

Demand for new vaccines and therapies in 2010 will be offset by concerns about drug prices and product safety.

Regulatory flexibility can make continuous improvement possible.

QbD has always embraced the notion that companies could make certain process changes without regulatory oversight.

Vaccine research and development is surging, but continues to face manufacturing and regulatory challenges.

Do we really have to choose between saving money and saving time?

What football and bioprocessing both have in common is that in both cases, success is a minimum requirement.

The focus on the design space will lead to a new workspace, and will affect staff in the development, manufacturing, and quality functions.

Conducting a FMEA analysis is a good first step in a risk-based approach for determining the need for a filter integrity test.

Heightened attention to product safety issues is slowing the approval process for new therapies.

It seems clear that insuring the roughly 46 million Americans who are now uninsured will increase drug sales.

Stiffer enforcement of quality standards aims to restore public confidence in agency actions.

If risk assessments only identify "the usual suspects," the process will not add much value.

ICH Q9 encourages companies to apply the concept of quality risk management. Easier said than done.

Perhaps the best way to regulate drugs is to regulate them not conservatively or liberally, but effectively.

The introduction of two rival bills has intensified the long-simmering debate on biosimilars regulation in the US.

The truth is, we should have been afraid of H1N1, because the threat of a flu pandemic is real.

The FDA seeks new strategies for improving the safe use of opioids and other high-risk medicines, including erythropoiesis stimulating agents.

Agency officials promise swift action against violators of drug safety and quality regulations.

Avoiding healthcare reform is not the best option for the pharmaceutical industry.

Authorities are pushing for CE; manufacturers prefer to focus on value.

Follow a risk-based approach to maintain a state of control.

The FDA is poised to gain more authority and resources to ensure product quality.

The 45 comments submitted raised concerns about legacy products and ongoing process monitoring.