Quality Systems

A single, global tooling standard would offer many benefits, but one has been slow to emerge.

The author describes key considerations for drug manufacturers when evaluating packaging partners.

A new audit guide aims to improve supply-chain security and supplier qualification practice.

The author provides an overview of QbD implmentation for biopharmaceuticals.

Just when things seem to be looking up, the unexpected problem occurs.

The authors review a compliance-by-design approach to quality systems.

Pharmaceutical Technology's annual survey on equipment and machinery reveals the spending levels and type of spending made in 2010 and planned for 2011.

As drug shortages make headlines, FDA tests the Sentinel safety system and its efect on healthcare.

INTERPHEX 2011 aims to address the industry's unique characteristics.

The Society of Chemical Manufacturers and Affiliates (SOCMA), in a statement submitted to the US House Subcommittee on Cybersecurity, Infrastructure Protection and Security Technologies, called for Congressional action to pass a three-to-five year authorization of current Chemical Facility Anti-Terrorism Standards (CFATS), which are scheduled to expire Mar. 4, 2011.

Gilead to Acquire Calistoga; Bayer Healthcare Appoints Former Pfizer Exec; and More.

HHS Releases a New National Vaccine Plan

President Barack Obama released his budget proposal for fiscal year (FY) 2012, which shows an increase in funding for the US Food and Drug Administration.

EMA Outlines Activities for 2011, and more.

US Senators Amy Klobuchar (D-MN) and Bob Casey (D-PA) introduced the "Preserving Access to Life-Saving Medications Act," which is intended to help address and prevent shortages of prescription drug medications.

My drug failed a light-obscuration test, but after I filtered the drug for microscopic particle counting, I couldn?t see any significant particulate on the filter. What might have caused the failure, and why is it not visible?

Developments during the past several years have led many industry professionals to question whether nonsterile dosage forms are being produced in a state of control.

The recent India–EU summit was expected to bring news about the upcoming Free Trade Agreement between the EU and India; however, a dispute regarding the supply of generic drugs from India to developing countries has taken centre stage.

India is set to become a "biosimilar powerhouse", with manufacturers in this country well placed to capitalize on the growing biosimilars market, according to market analysts at Datamonitor.

According to the UK's Economic and Social Research Council (ESRC), the closure of Pfizer's UK R&D facility, announced last week, is part of a long-term decline in drug development that is affecting all major UK pharmaceutical multinationals.

On Feb. 4, 2011, the European Medicines Agency released new document on drug products that are manufactured using stem cells.

The Society of Chemical Manufacturers and Affiliates (SOCMA), in a statement submitted to the US Senate Subcommittee on Superfund, Toxic and Environmental Health, provided support for a bipartisan review of the Toxic Substances Control Act (TSCA) as that subcommittee considers reforming the  chemical control law.

Last Thursday, the US Senate scheduled the Patent Reform Act of 2011 for debate after the Senate Judiciary Committee passed the bill.

The United States Pharmacopeial Convention (USP) launched a 12-month pilot Technical Assistance Program (TAP) to provide developing countries in sub-Saharan Africa with greater capacity to test the quality of medicines.

President Barack Obama's State of the Union address, delivered last week on Jan. 25, 2011, to the US Congress, was largely well received by the pharmaceutical and biotechnology industries.

The European Medicines Agency has released a new Annex 11-Computerized Systems to its GMP Guide Chapter 4 on Documentation to account for the increased use of and complexity of computerized systems in the drug-manufacturing community.

FDA Holds Workshop on Orphan Drugs

Last Friday, Senators Herb Kohl (D-WI) and Chuck Grassley (R-IA) reintroduced their "Preserve Access to Affordable Generics Act," which would presume that pay-for-delay settlements were illegal and give the Federal Trade Commission (FTC) the power to block them.

Chemistry reviewers in FDA's Office of Generic Drugs provide an overview of common deficiencies cited throughout the CMC section of ANDAs.

Follow-ons were all the rage at this year's JP Morgan Healthcare Conference.