Quality Systems

Managers of FDA-regulated firms must be proactive in how they manage their company?s compliance with good manufacturing practices regulations.

The C-SOC team must develop a network of committed industrial partners who will participate in the direction, execution, and evaluation of research and educational activities.

An increasing number of new compounds are being introduced into pharmaceutical pilot plants.The knowledge base for these compounds regarding their toxicities,physical handling, and cleaning is limited.The authors examine various approaches for addressing the cleaning validation of new compounds and discuss the role of determining appropriate visible residue limits.

At its 2005 Convention, USP passed 13 resolutions that will help define the organization’s path for the next five years and represent the interests of its diverse constituency.

Innovators and generics makers are staking out positions on follow-on proteins and other manufacturing issues.

Managers of FDA-regulated firms must be proactive in how they manage their company's compliance with good manufacturing practices regulations.

The validation of alternative microbiological testing is an opportunity for a manufacturer to decrease the amount of time required for laboratory results. To properly validate these alternatives, a practitioner must first identify what is being studied. The regulatory effect on established product and process specifications and levels must be completely evaluated, as changing the method of analysis may well change the apparent number in the sample.

FDA Finalizes Guidances on Minimizing Drug Risk and Submitting Pharmacogenomic Data

FDA New Drug Review Times Continue to Drop in 2004

USP to Publish Spanish Translation of USP-NF; Council of Experts Named

Warning Letters: DanChem Technologies & Medsep

US Marshals Seize Supplies of GSK Paxil CR, Avandamet

UK MHRA Okays Chiron Flu Vaccine Plant; FDA Approval Still to Come

FDA Approves Treatment for Smallpox Vaccination Side Effects

pharmaceutical science and technology news

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