Quality Systems

IPEC-Americas has just completed a major update to its significant change guideline to address current issues in the manufacture of excipient ingredients and to assist manufacturers in developing an impurity profile.

In this time of liability reform, pharma deserves the chance to align its economic interests with its ethical obligations to the patient.

As newer and more elaborate hardware and software systems are installed in automated manufacturing environments, companies are further incorporating good practices into their validation process.

New fixed-dose combination drugs aim to enhance safety and efficacy, while regulators clear a path for more drug–device combination products.

The author describes strategies for analytical method development that are helpful in achieving quality by design and efficiency.

CBER Draft Guidance for Spore-Formers and Plasmid Vaccines

FDA Creates New Drug Safety Board

NIH Prohibits Employees from Collaborating with Pharmaceutical Companies

Drug Safety Top Issue for New FDA Commissioner Crawford

SAFE Electronic Identity Standard for Drug Industry

FDA Reopens Comment Period on Biological Products Development Workshop

FDA's $1.9 Billion Budget Proposal Banks on User Fee Revenues

Steer small.

The Impurity Profiling Group reviews stress testing according to regulatory guidance documents. The authors emphasize what should be considered for late clinical phases and for registration application dossiers.

Pharmaceutical Science & Technology News

The USP prepares for its quinquennial conference in March.

Analytical instrument suppliers are developing manufacturing-tailored tools that are small, precise, and easy to use.

Concerns about risky medicines may reduce pressure to expand drug imports while boosting demand for more comparative analyses of therapies.

The United States Pharmacopeia should not change its philosophical position on singlet testing.

European Directive 2004/27/EC will have massive repercussions on the manufacture and marketing of APIs and some excipients across Europe...

A look at how process analytical technology promises to be the most radical change in pharmaceutical manufacturing in 30 years...

A look at the role of document management in the product life-cycle and how this can lead to the effective use of CTDs and e-CTDs when compiling compulsory regulatory submissions...

FDA cites Essential Pharmacy Compounding (Omaha) for bulk-compounding of verterinary drugs.

ISA-88 Automation Standard Gains IEC PAS Status

FDA Warning Letters December 2004

NABP Issues Criteria for "Specified List" of Drugs Susceptible to Diversion

Safety issues and shortages may slow down new drug development and FDA reforms

Comparative studies of the US Pharmacopeia (645) "Conductivity" and the European Pharmacopeia "Heavy Metals" tests were conducted to demonstrate that the USP method can determine the presence or absence of heavy metals in process water samples.

Pharmaceutical Science & Technology News

Pat Survey