Analytics

The growth and globalization of the pharmaceutical supply chain make risk assessment more important than ever for pharmaceutical manufacturers. The authors describe a program to identify, prioritize, mitigate, and communicate risks in manufacturer–supplier relationships.

The biggest benefit of PAT and the current FDA initiatives may be in allowing pharmaceutical scientists to use their technical capabilities to improve pharmaceutical processes.

Also, Zentiva accepts Sanofi's increased takeover bid, Oriel Therapeutics appoints Richard Fuller CEO, more...

Also, Quintiles to expand Singapore operations; Christine A. Poon, chairman of Johnson & Johnson's pharmaceuticals group, to retire; more...

Also, Human Genome Sciences enters pact with Hospira, Zosano Pharma names Gail Schulze chair and CEO, more...

USP announced an interim revision to its monograph for levothyroxine sodium tablets, which will become official in USP 32-NF 27.

Also, Novartis stops development on "Aurograb," Zealand Pharma appoints David H. Solomon as CEO, more...

The US Food and Drug Administration will hold a public meeting this month to gain public input on implementing the recommendations of the Nanotechnology Task Force report, taking another step closer to setting a regulatory framework for nanotechnology for pharmaceuticals and medical devices.

Equipment qualification is a critical step in ensuring that a product or service is provided accurately and consistently with regards to manufacturing and testing. The time-saving attribute of adding prerequisites to a qualification program, along with the benefit of gaining the ability to track and trend problem areas, make the addition both worthwhile and cost-effective.

Brief pharmaceutical news items for September 2008.

This year, the employment survey will acknowledge the industry's best employers.

This tutorial paper is meant to aid in dielectric-sensor selection

Are hypersanitation trends a result of scaremongering or a lack of faith in medicine?

The authors describe the Piers' catalysts and detail latest progress in olefin-metathesis catalyst technology.

EPedigree, track-and-trace technologies, and other tools for optimizing supply-chain management are of increasing importance to the pharmaceutical industry. The author examines the current regulatory and legislative framework for ePedigree for finished drug products as well as proposals to require electronic statements for pharmaceutical ingredients.

The US Food and Drug Administration will hold a public hearing Oct. 2, 2008, to obtain input regarding over-the-counter (OTC) cough and cold drugs marketed for pediatric use.

The deadline for nominations for the Innovations in Pharma Science Awards is here. Check out http://pharmtech.com/Innovations to nominate your company's work in one of five areas by next week

Also, Shire recalls "Daytrana" patch, Chromatide forms Scientific Advisory Board, more...

The US Pharmacopeial Conventional added to its international sites with the official opening of its facility in Sao Paulo, Brazil.

Also, Tekmira will collaborate with Bristol-Myers Squibb, Helicos Biosciences appoints Steve Lombardi CEO, more...

Actavis Totowa LLC, the US subsidiary of the generic drug manufacturer Actavis Group, is announcing a voluntary recall to the retail level of all drug products manufactured at its Little Falls, New Jersey, facility. This is a precautionary, voluntary action by Actavis following an inspection conducted by the Food and Drug Administration earlier this year.

The US Food and Drug Administration has distributed a draft of Guidance for Industry: Residual Solvents in Drug Products Marketed in the United States for public comment.

Also, Ortho Biotech recalls one lot of "Procrit" due to cracked vials, more appointments at Actavis, more...

Also, Bilcare Global Clinical Supplies opens new headquarters in San Francisco, Sigurdur Oli Olafsson named CEO of Actavis Group, more...

Legislative decisions to increase Medicare's formulary may lead to a fight over drug approvals.

The authors propose an alternative to the USP disintegration test method. The method embraces physiological conditions of the oral cavity, as a screening tool for developing ODT products.

The authors consider several common techniques for verifying the accuracy of liquid-handling equipment and offer guidance for finding the appropriate technique for a given instrument.

Extractables and leachables are a growing concern for pharmaceutical manufacturers and regulatory bodies.

The high-profile case of contaminated heparin from a Chinese supplier has intensified the debate on the effectiveness of FDA's process for inspecting foreign drug-manufacturing facilities. The article examines proposed legislative and regulatory reforms and actions taken by the agency to improve drug-import safety.

Also, Cobra Biomanufacturing to extend collaboration and form joint venture with ViroMed, Epix Pharmaceuticals CEO resigns, more...