Quality Systems

Parameters for steam-sterilization autoclave overkill cycles should be chosen based on process understanding.

Vaporous hydrogen peroxide, nitrogen dioxide, chlorine dioxide, and carbon dioxide technologies can be used in pharmaceutical manufacturing to sterilize or disinfect.

During the ongoing federal government shutdown, FDA activities will be limited to work involving the safety of human life or the protection of property, and activities funded by carryover user fee balances PDUFA, GDUFA, and MDUFA.

Budget issues and changing global markets are prompting FDA to revise its growing network of overseas offices.

The pharmaceutical industry grows despite conflict in the Middle East.

Kurt Lumsden, Director Client Services at Perceptive Informatics, a subsidiary of PAREXEL, discusses regulatory requirements for the drug accountability process.

Recent FDA enforcement activity reveals issues with vial-filling, adequacy of QA/QC procedures, particulate matter in inhalation powders and injectables, and drug labeling.

Foreign companies zero in on Myanmar with the hope of securing a foothold in its pharmaceutical market.

The authors discuss a strategy for developing a risk-based approach for testing of elemental impurities in leachable studies.

Manufacturing standards are considered key to preventing drug recalls and shortages.

FDA publishes guidance on ANDA submissions.

EMA revises HIV treatment guideline.

Boehringer Ingelheim initiates a recall due to the potential for extrinsic foreign particles in the API used to manufacture Spiriva Handihaler (tiotropium bromide inhalation powder) capsules.

New weapons in the anticounterfeiting arsenal include authentication and labeling technologies.

Shamrock Medical Solutions Group, a drug repackaging and distribution company, repeatedly failed to comply with good manufacturing practices.

EMA releases details of restructuring.

FDA issues import alert due to cGMP violations at Ranbaxy's facility in Mohali, India.

FDA reports that Hospira initiated on July 12, 2013 a voluntary recall of certain lots of bupivacaine HCl due to particulates floating and/or in the glass vial.

FDA updates guidance to reflect advances in technology.

FDA specifies the DUNS UFI system for registration of domestic and foreign drug establishments.

The association representing the research-based pharmaceutical industry in Europe is concerned that an EMA policy will put transparency ahead of public-health interests.

McNeil Consumer Healthcare Division of McNeil-PPC announced a voluntary recall of three lots of Motrin Infants? Drops after 1 mm plastic particles were identified in a different product lot during manufacturing.

Draft guidance recommends in-vitro and in-vivo studies to establish bioequivalence.

Regulatory Authorities Discuss Elemental Impurities Standards

FDA inspections reveal possible inaccurate sterility testing.