Quality Systems

Washington, DC (Dec. 28)-The US Department of Homeland Security (DHS) has proposed regulations for improving security at high-risk chemical facilities, a category that may include some pharmaceutical production facilities.

An adulteration limit of 100 ?g/25cm? (4 ?g/cm?) was proposed for pilot-plant facilities. The dynamic changes in equipment, formulation, and residue determination made implementation of a constantly changing, calculated adulteration limit impractical. A single adulteration limit was simpler to communicate and document, making compliance achievable. The limit would be used only after it was determined to be lower than a health-based evaluation and a visual-cleanliness assessment.

During the past decade, the pharmaceutical industry has increased its use of information technology (IT) in research and development, production, and commercialization of pharmaceutical products. IT systems must be operated and maintained within a compliance-oriented framework to minimize risks; maximize safety and security, integrity, accuracy, reliability of information; and maintain product quality, For IT vendors and service providers, meeting requirements for qualification and validation calls for substantial investments in terms of creating capability, expertise, and resources. The author discusses the implications, challenges, and solutions in managing IT infrastructure qualification and validation in an FDA-regulated environment, particularly at vendor sites.

The closing presentation was perfectly pitched to bring a lump to our throats and have us cheering for fast-track drug development. I and 30 other journalists had spent the day touring a Big Pharma plant, and now sat shoulder to shoulder in a warm conference room, awaiting the final speaker.

Defects in Herceptin vials stem from a fault in the packaging process.

The production staff was sure the lab couldn't test their way out of a paper bag.

Pharmaceuticals current good manufacturing practice (CGMP) violations accounted for just 36 of the 441 Warning Letters issued by the US Food and Drug Administration in 2006.

Symposium held at 2006 AAPS Annual Meeting in San Antonio

US District Court for the Eastern District of New York Magistrate Judge A. Kathleen Tomlinson's Nov. 30 2006 "Report and Recommendation" supporting a preliminary injuction requested by the plaintiffs in RxUSA Wholesale, et al v. FDA.

Washington, DC (Dec. 13)-After considerable debate and negotiation, Congress this week passed four bills poised to affect pharmaceutical and biotechnology research, development, and manufacture. All are currently awaiting signature by the President.

Rockville, MD (Dec. 12)-The US Food and Drug Administration is proposing amendments to its final rule regarding labeling requirements for convenience-size over-the-counter human drugs.

Dec. 11, 2006 (Rockville, MD)-Effective Jan. 16, 2007, Scott Gottlieb, MD, deputy commissioner for medical and scientific affairs at the US Food and Drug Administration, will leave the agency and will return to the American Enterprise Institute.

Rockville, MD ( Dec. 4)-The U.S. Pharmacopeia plans to open a 10,500-square-foot site in Shanghai in February 2007. The facility, in Shanghai's Zhangjiang Hi-Tech Park, will support collaborative testing, technical assistance, customer service, and training.

Washington, DC (Dec. 7)-One of the last acts of outgoing Senate majority leader Bill Frist (R-Tenn) was to push through confirmation of Andrew von Eschenbach as the official head of the Food and Drug Administration.

Brand-name manufacturers seek to protect their products.

Poor support of drug- and process-development training programs will affect industry's future growth.

The US Pharmacopeia (USP), the Japanese Pharmacopoeia, and the European Pharmacopoeia "Microbial Limits Tests" are in the final stages of harmonization. The harmonized USP chapters are slated for implementation in 2009. This article describes the harmonized USP Chapters <61> "Microbial Enumeration," <62> "Absence of Specified Microorganisms," and <1111> "Microbiological Attributes of Nonsterile Pharmaceutical Products," and suggests they will likely require some revalidation of existing methodologies. Companies should put plans in place immediately for this work and show consistent progress towards this goal.

We really knew what we were doing-until we opened the column for a routine repacking.

Proof of concept is a new development paradigm.

EFPIA's 'Mock P.2' document aims to show how the role of 'quality risk management' and process analytical technology as an enabler for quality by design can be presented in a common technical document format. This article summarizes the main features of this document, and explains the key concepts and principles used.

London (Nov. 22)-The European Medicines Agency reports a defect in some vials of Herceptin (trastuzumab), the anticancer treatment by Roche, which have been distributed in Europe. As a result, The EMEA's Committee for Medicinal Products for Human Use outlined a plan, formulated in conjunction with Roche, for the visually reinspecting and replacing defective vials.

Basel, Switzerland (Nov. 17)-Novartis plans to submit additional information to the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency on manufacturing issues to support the approval of its antifungal drug "Mycograb." The CHMP issued a negative recommendation for the drug.

Washington, DC (Nov. 13)-The Biotechnology Industry Organization is urging the World Health Organization to assign a distinct international nonproprietary name (INN) to each unique biological product, including follow-on biologics or biosimilars.

Over-the-counter drug maker Perrigo Company issued a voluntary recall of certain lots of store-brand acetaminophen 500-mg caplets that could contain trace amounts of metal particulate. Approximately 11 million bottles of acetaminophen are affected by the recall.

Mystic, CT (Oct. 26)-Kenneth G. Chapman died at his home here on Oct. 26. He was 79. The cause was pancreatic cancer

Dallas, TX (Nov. 7)-The US Food and Drug Administration has posted a Warning Letter from its Dallas District office to Matheson Tri-Gas, Inc.

AAPS, San Antonio (Oct. 31)-Industry and regulatory agency concerns over process variability have prompted both groups to take a closer look at analytical method transfer processes.

AAPS, San Antonio (Oct. 31)-Excipient manufacturers are raising concerns over recently adopted European guidelines, set to become effective January 1, 2007, which provide a framework and approach for dealing with genotoxic impurities in new active substances.

Liverpool, UK (Oct. 20)-Novartis Vaccines and Diagnostics Limited is recovering two lots totaling 500,000 doses of its ?Fluvirin? influenza virus vaccine after reports that the product had been received from distributor Cardinal Health Care in either a frozen state or below the required storage temperature range of 35?46 degrees F.

The correlation between swab assay results and visible-residue limits (VRLs) for cleaning validation was examined. Previously completed validation studies were reviewed to compare swab results with recently determined VRLs. A current cleaning validation study evaluated both swab testing and VRL. Unexpected swab results led to an investigation, which showed the value of establishing the VRL in conjunction with swab recoveries for cleaning validation programs.