Quality Systems

This article presents an overview of ISPE's guide on project management.

The author discusses the key provisions of GDUFA as they relate to the pharmaceutical supply chain, including parity of inspections between domestic and foreign sites for both finished dosage forms and APIs of generic drugs.

The Johnson & Johnson subsidiary Janssen Pharmaceuticals has announced a settlement and consent decree with 36 states and the District of Columbia in regards to previously disclosed allegations related to the company's marketing and promotional practices relating to Risperdal (risperidone).

The European Medicines Agency has recommended that the anticancer medicine DepoCyte be recalled from EU countries following the discovery of manufacturing deficiencies at Pacira Pharmaceuticals' San Diego site.

Regulatory Roundup: ISPE issues ozone sanitization guidance and EMA amends incident management plan

Manufacturers willing to report bad news about the supply can help reverse the shortage trend.

After a series of government reforms that are appealing to both domestic and foreign players, the Japanese pharmaceutical market is making a comeback.

The author discusses strategies for preventing cargo theft.

Import controls and risk strategies aim to promote quality and spur new drug development.

The authors compare direct combustion with rinse and swab sampling methods.

The author discusses how to manage pending pharmacopeial changes.

No matter the upside or downside to the Affordable Care Act, there's work to be done.

Applying the recommendations of ICH Q10 to statistical analysis can help prevent product recalls.

IQ Consortium representatives explore industry approaches and practices for applying GMPs in early development.

New law provides FDA with the resources it needs to safeguard drug supply chain.

Meticulous system configuration can prevent machines from taking over.

The authors, part of the International Consortium on Innovation and Quality in Pharmaceutical Development (IQ Consortium), explore and define common industry approaches and practices when applying GMPs in early development.

The author discusses how a CDMO helps in gaining process understanding and in developing robust, high-quality products and processes.

FDA announces FY 2013 user fee rates and EMA furthers relationship with Japan.

A report from the European Commission shows that fake pharmaceuticals were the top articles detained by European Union customs in 2011.

A roundup of industry regulatory news.

Experts share insights into analytical tools and techniques.

FDA promotes supply chain pilot program. EMA opens pharmacovigilance legistation up for public consultation. USP Calls for Somatropin Cell-Based Bioidentity Method.

On July 9, 2012, Congress passed the Generic Drug User Fee Act in an effort to expedite the process of bringing generic drugs to market. The Act authorizes the collection of user fees from generic-drug manufacturing companies for the first time in the industry's history.

ISPE has issued a guidance that is intended to help companies meet cGMP requirements for packaging, labeling, and warehousing facilities and avoid problems such as product adulteration, product mix-up, label mix-up, and misbranding.