Quality Systems

Kurt Lumsden, Director, eCDS Client Services at PAREXEL Informatics, discusses eClinical supply-chain management.

How badly is Brazil's pharmaceutical market suffering from the global instability of emerging markets?

New identifiers and tracking requirements aim to block illegitimate products.

As Europe strives to firmly incorporate quality-by-design principles, there are several key issues that still need to be addressed.

China's regulatory and compliance environment is set to change as the government declares a crackdown on bribery scandals.

GSK recalls alli weight loss products in the US and Puerto Rico.

FDA has announced Fresenius Kabi USA, LLC of Lake Zurich, Ill., will temporarily distribute normal saline in the United States from its Norway manufacturing facility.

Looking to improve patient access to new medicines, EMA creates a pilot project to explore an adaptive licensing approach with real medicines in development.

New injection-delivery systems with multiple closure points pose challenges for container closure integrity testing.

HHS plan makes progress in ensuring availability of safe vaccines.

Agencies extend successful pilot program to further harmonization of QbD topics.

New guidance from FDA asks for documentation of CMC postapproval manufacturing changes.

Quality-by-design principles enhance a thorough understanding of both product and process technology, which is needed for optimization of solid-dosage manufacturing, including processes for improving solubility, such as hot-melt extrusion, softgels, and liquid-filled capsules.

Manufacturers are taking measures to comply with new package safety rules.

China's regulatory and compliance environment is set to change as the government declares a crackdown on bribery scandals.

Accelerated testing and production create challenges in documenting product quality.

Using best practices for manual or automatic inspection can improve the inspection process.

A survey on postapproval CMC changes was conducted to better understand reporting categories, nature and risks, and review outcomes.

The root cause of drug shortages is mismanagement of variation.

USP evaluates quality attributes for synthetic peptides.

Discovery of split and broken tablets led to drug recalls.

FDA revises interpretation of the five-year NCE exclusivity provisions for certain fixed-combination drug products.

Daiichi Sankyo announced suspension of API shipments from Ranbaxy's Toansa and Dewas plants; issues apology to stakeholders.

FDA and EMA set up regular meetings to harmonize drug safety actions.

FDA provides recommendations for submitting analytical procedures and methods validation data.

USP's revised Chapters 41 and 1251, which became official in December 2013, have new requirements for weighing, including balance calibration and testing.

Thirteen companies are accepted for participation in the supply chain program.

Tandem Diabetes Care expands its voluntary recall of select lots of insulin cartridges used with t:slim insulin pump.

NSF-IPEA now can provide excipient auditing and certification.

EMA releases an update on its flu vaccine guidance.