Quality Systems

There is a need for current cleaning validation methods to be used for topical formulations. The authors highlight the issues and challenges encountered.

With 2007 projects wrapped up, or so we hope, forward-looking companies need to take their next step.

FDA’s May 1999 container-closure guidance has accelerated the requirements for extractable and leachable testing of container-closure packaging components. Since that date, additional recommendations have been made by industry groups to clarify how these issues should be addressed.

Fixing FDA lies in the hands of the government, but is the president-to-be paying attention?

Pharmaceutical manufacturers often avoid putting new excipients in their formulations for fear of more regulatory oversight. IPEC has a solution.

Process efficiency is measured not only by what is kept, but also by what is thrown away.

As FDA implements new drug-safety policies, manufacturers will focus on quality and pricing.

QbD, PAT, design space, what's it all about? This seems to be a common industry response to FDA's directional push.

How much do you know about parallel trade? Perhaps you may have heard someone mention these words and have then switched off. In a sense, it's hardly surprising given the fact that most media coverage centres on interpretation of complex legal cases. By the time you reach the end of these types of articles, you can't work out what the mentioned companies were arguing about in the first place and on which technical details the case was judged. Yet, time after time, a legal ruling on a parallel trade issue rockets to the front pages of the pharmaceutical press and even, occasionally, the mainstream media.

The US Food and Drug Administration's joint panel of the Nonprescription Drugs Advisory Committee and the Endocrinologic and Metabolic Drugs Advisory Committee voted against recommending approval of the over-the-counter use of Merck & Co.'s “Mevacor” (lovastatin) 20 mg.

Merck & Co. initiated a voluntary recall of 11 lots of its Haemophilus influenzae type B vaccine, Pedvaxhib, and two lots of its combination Haemophilus influenzae type B/ hepatitis B vaccine, Comvax.

Company and People Notes: West to reduce workforce, Eli Lilly's CEO and chairman to retire, more...

After a negative year in the news, China has finally agreed to improve the safety of its drug and food exports, according to the US Department of Health and Human Services.

The US Food and Drug Administration posted on its website a Warning Letter it sent to Wyeth Pharmaceuticals regarding a journal advertisement for the company?s ?Effexor XR? antidepressant.

The US Food and Drug Administration issued a rule that clarifies its requirements for current good manufacturing practices for aseptic processing, water standards, and verifications standards.

Tomorrow, Dec. 14, the US Food and Drug Administration?s Nonprescription Drugs Advisory Committee will discuss the safety and effectiveness of over-the-counter (OTC) cold medications containing phenylephrine.

The European Commission has approved Torisel (temsirolimus) for the first-line treatment of patients with advanced renal cell carcinoma (RCC), a condition that accounts for more than 80% of the estimated 85000 new cases of kidney cancer diagnosed in Europe every year.

Chi-wan Chen, deputy director of the Office of New Drug Quality Assessment (ONDQA) at the US Food and Drug Administration's Center for Drug Evaluation and Research, shares insight from FDA's pilot program that was designed to allow pharmaceutical companies to submit CMC information demonstrating application of quality by design.

Congress Focuses on FDA Inspections of Foreign Drug Facilities; Medical Students Oppose Big Pharma's Influence on Campus; FDA Revises Postmarketing Reporting Requirements

There are at least two major factors that will shape the manufacturing industry as a whole. Daniel Ruppar, Industry Manager (North America) for the Pharmaceuticals and Biotechnology Division of Frost & Sullivan predicts that, due to continued globalization, we can expect to see "growth centers for the industry move to emerging market sectors."

To keep up with applications, FDA promotes new testing and administrative methods.

How do you answer an inspector's questions? How do you validate analytical methods? One book has answers for compliance professionals.

The "why" things are done in this industry is just as important as the "what"and "how."

"May you live in interesting times," goes the allegedly ancient Chinese curse. Well, these have been "interesting times" indeed for those working in the pharmaceutical industry.

Company and People Notes: ISP to raise prices, Patheon appoints CEO, more.

The US Food and Drug Administration has issued Ben Venue Laboratories a Warning Letter resulting from CGMP deviations found during an inspection of the company?s ?Propofol? injectable emulsion manufacturing facility earlier this year.

The US Government Accountability Office issued findings that are largely critical of the US Food and Drug Administration in managing its inspections of foreign drug-manufacturing facilities.

The Interagency Working Group on Import Safety issued its action plan for ensuring the safety of imported products, including drugs, food, and consumer products, into the United States.

The Bulk Pharmaceuticals Task Force, an affiliate of the Synthetic Organic Chemical Manufacturers Association (SOCMA) weighed in on the Congressional debate concerning the US Food and Drug Administration?s inspection process of foreign drug- manufacturing facilities.

Looking to resolve litigation over Vioxx (rofecoxib), Merck & Co reached an agreement to settle the vast majority of Vioxx claims for $4.85 billion.