Quality Systems

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.

Industry and regulatory experts discuss the challenges and benefits of implementing real time release testing in a pharmaceutical manufacturing environment.

As biologic-drug patents move toward expiration in the US, Indian firms with experience in the follow-on biologics arena are eager to partner with global manufacturers and secure their place in the growing biosimilars market.

Legislation has hampered cross-border drug importation and limited choice.

Food-safety, transparency, and counterfeit-drug growth will tax agency resources.

USP helps to improve drug quality in 32 countries.

Taking care to note, file and re-check information can save one from future mishaps.

Using risk assessment properly can provide industry with a unique tool for quality control.

Nearly six years after applying, the FDA joins the Pharma Inspection Co-operation Scheme.

How to adapt a real time release approach to powder processing during drug-product manufacturing.

The author describes why statistical significance would impose an unreasonable burden on manufacturers.

Innovations protect the quality of temperature-sensitive products.

FDA published its long-awaited guidance titled Process Validation: General Principles and Practices this week.