Manufacturing

The future of pharmaceutical R&D may lie in open-source research, with key data being made available to a number of people, including college students and university researchers, in an open and collaborative process.

US Department of Health and Human Services (HHS) Secretary Kathleen Sebelius released last week an examination of the federal government's system to produce medical countermeasures, or medications, vaccines, equipment, and supplies needed for a health emergency.

Two new reports describe the vaccine market's recent growth and predict future market expansions.

Members of a UK trade union working at AstraZeneca have voted to strike following cuts in pension benefits.

The US Food and Drug Administration and European Medicines Agency (EMA) are looking for drug manufacturing companies to participate in their joint good manufacturing practice (GMP) inspection pilot program.

The Society of Chemical Manufacturers and Affiliates (SOCMA) welcomed the signing of HR 4380, the United States Manufacturing Enhancement Act of 2010, also known as the Miscellaneous Tariff Bill (MTB) into law (Public Law 111-227) by President Barack Obama on Aug. 11, 2010.

Eli Lilly Ends Semagacestat Program; Selecta Appoints CEO; And More.

PharmTech's monthly newsletter, Equipment and Processing Report, reviews the Editor's Picks for the August 2010 edition from Lechler and Thermo Fisher Scientific.

Changing or upgrading cleanroom gloves requires time and due consideration. A good decision could improve employee satisfaction and product yields, but a bad decision could necessitate millions of dollars worth of rework, recalls, and rejects if the gloves don?t perform as expected. Personnel should consider various criteria to choose the best glove for their cleanroom.

Making highly potent active pharmaceutical ingredients (HPAPIs) can be costly because the process often requires equipment specialized to achieve containment and extra attention to safety concerns. Pharmaceutical professionals may wonder whether disposable components, which have reduced the cost of some operations, might be appropriate in the manufacture of HPAPIs.

Sen. Michael Bennet (D-CO) introduced a bill earlier this month, the Drug Safety and Accountability Act of 2010, which is designed to improve regulatory oversight of drug-manufacturing facilities and improve related quality standards and monitoring.

Merck & Co. (Whitehouse Station, NJ) has received letters from the US Department of Justice (DOJ) and the US Securities and Exchange Commission (SEC) seeking information about "activities in a number of countries" with reference to the Foreign Corrupt Practices Act.

This week, the US Food and Drug Administration published on its website a summary of good manufacturing practices for the holding and distribution of drug products.

Penwest and Endo to Merge; Watson Makes Senior Appointments; And More.

In a draft guidance published this week, the US Food and Drug Administration recommended that makers of transdermal and transmucosal drug-delivery systems use "an appropriate scientific approach" during product design, development, and manufacturing to minimize the amount of residual drug substance present at the end of the products' labeled use periods.

FDA Approves Flu Vaccines; Caraco Names COO; And More.

Legislative efforts to modernize provisions in the Toxic Substances Control Act of 1976 (TSCA), which involve chemical safety and reporting requirements is drawing criticism from the chemical industry.

The updated edition of William Whyte's book provides information for novices and seasoned professionals alike.

Serialized product codes serve as the foundation of ePedigree records and product traceability.

Fallout escalates from McNeil recall and Genzyme shortages as regulators review oversight.

Industry's focus on cost cutting has led to a dangerous gap in training and knowledge.

The authors discuss the statistical tools used in experimental planning and stategy and how to evaluate the resulting design space and its graphical representation.

Cases of overlooking proper packaging, reconstitution, directions, and dissolution.

Manufacturers and regulators on both sides of the ocean move to ensure the safety of heparin and other globally distributed drug products.

Industry can meet its responsibility to society by considering innovative pricing and partnerships.