Quality Systems

Control charts that are properly constructed and maintained prevent false out-of-control signals and provide a useful method for monitoring a process.

FDA issues a warning letter to Zhejiang Jiuzhou Pharmaceutical Co., Ltd. and its import/export company for multiple CGMP violations and misbranded products.

American Health Packaging announced a voluntary nationwide recall of ibuprofen and oxcarbazepine tablets due to mislabeling on the inner unit dose blister packaging.

Unique Pharmaceuticals has issued a voluntary recall of sterile compounded preparations, but aired concerns about FDA?s recall demand.

Baxter investigates root cause of cellulosic fibers and/or plastics in four lots of IV solutions.

Trifarma cited for significant deviations in data collection and security, and employee training.

Sun Pharma, Forest Pharmaceuticals and West-Ward Pharmaceuticals issue recalls over dissolution issues.

Baxter Healthcare has initiated a nationwide recall of more than 20,000 containers of a pre-mixed beta blocker due to the presence of particulate matter.

The European Medicine Agency details the agency?s recommendations for drug-marketing authorizations for the first half of 2014.

FDA clarifies GDUFA requirements in regards to abbreviated new drug applications and prior approval supplements.

The authors look at the cleanability of pharmaceutical soils from a variety of materials of construction to determine the relative ease of cleaning and explore potential grouping strategies as part of a comprehensive cleaning validation program.

The right approach can provide a clear, statistically defendable method for determining dissolution and accelerated stability.

Siegfried Schmitt, Principal Consultant, PAREXEL International, discusses how to ensure data integrity.

Several groups, including pharmacies, call on FDA to preserve accepted International Nonproprietary Name conventions for biosimilars.

Nitrogen dioxide can sterilize and depyrogenate an aseptic fill area in a blow-fill-seal process.

FDA draft guidances seek to maintain accurate drug information for patients in new media.

Is there potential for growth in Brazil's phytotherapic drug market?

Stakeholders face challenges and benefits from a more secure pharmaceutical supply chain.

Regulators and industry leaders take on the task of securing the drug supply chain.

FDA releases guidance documents and rules on requirements for compounding human drug products.

European Medicines Agency clarifies advanced-therapy medicinal products classification.

Bristol-Myers Squibb issues a voluntary US recall of Coumadin (warfarin sodium) for injection due to presence of particulate matter.

Regulators and industry organizations explain policies and standards to manufacturers and authorities across the globe.

GSK Biologicals receives warning about cGMP compliance issues at its Quebec facility.

FDA cites cGMP violations for API manufacturing at a facility in Tianjin, China.

FDA inspection found cGMP violations in the Bangalore, India API manufacturing facility.

EDQM details the agency?s accomplishments in 2013.

FDA issues guidance on the use of social media in regards to prescription drugs.

ISPE Metrics Pilot Program is designed to demonstrate the feasibility and value of standard quality metrics.

FDA provides advice to supply-chain stakeholders on how to identify suspect drug products and how to notify the agency of those products.