Quality Systems

Schering-Plough Meets FDA Deadline for CGMP Improvements

The benefits of zero tolerance as a test criterion have been oversold. A critical examination of zero tolerance reveals that many of the supposed benefits are not attainable. More important, inappropriate application of this criterion can have a deleterious effect on the assessment, control, and improvement of the quality of pharmaceutical products.

Repercussions from the recent courtroom problems relating to the painkiller Vioxx and patent expiration have forced Merck to take cost-cutting action. In an effort to save money, the company has closed five factories and three research institutes, and will cut 7000 jobs.

Pharmaceutical industry regulation is about to change with a new code of practice. This has been revealed by the Association of the British Pharmaceutical Industry (ABPI) following recent problems with patient safety and the dissemination of data and information of approved drugs, which exposed loopholes within the code.

Using the Bergum Method and the MS Excel software program, the author determines the probability of passing the USP dissolution test.

In the second half of this two-part series, the author suggests that to qualify and validate a pharmaceutical manufacturing facility, one must coordinate protocol and SOP development, scheduling and implementation, turnover package preparation, and the management and resolution of deviations and discrepancies. In combination with the programs described in Part I, these activities will help deliver projects on schedule, at estimated cost, and with quality assured.

Merck (Whitehouse Station, NJ, www.merck.com) has revealed the "first phase" of its global restructuring program set to eliminate 7000 jobs (11% of its global workforce) by the end of 2008, close or sell 5 of its 31 manufacturing facilities, and roll out a manufacturing strategy to "drive significant efficiencies, decrease headcount, and reduce or refocus operations throughout the plant network and the entire manufacturing division." The company also expects to close one basic research site and two preclinical development sites.

A particular dermatological product was packaged in a metal tube, which is filled from the bottom.

FDA Sees Hike in Combination Product Applications

FDA issues a warning letter to Nephron Pharmaceuticals.

SEC Loosens Revenue-Recognition Rules for Vaccine Stockpile Participants

FDA Warns Consumers Against Unapproved, Contaminated 'Miracle II Neutralizer'

To qualify and validate a pharmaceutical manufacturing facility, one must carefully review the facility design for compliance with good manufacturing practices and manage project scope definition, labor and cost estimating, and master-plan development.These activities, properly implemented, help deliver a validated facility on schedule, at the estimated cost, and with expected quality.

A new oral dosage product was designed as "encapsulated tablets." In production, the drug product was pressed into tablets, which were then fed into a revolving capsule-filling table.

If judges and juries lack the scientific knowledge to decide drugsafety cases, how can we protect both companies and patients?

CDER is reorganizing staffs and developing new policies to encourage industry adoption of quality production systems.

Roche (Basel, Switzerland, www.roche.com) has put a temporary halt on the distribution of the antiviral treatment, "Tamiflu" (oseltamivir phosphate), a neuraminidase inhibitor, to the United States in an effort to deter companies from stockpiling the antiviral for employee use, according to an article in the Oct. 27 edition of The New York Times.

Particle shape is an important parameter to monitor in the pharmaceutical sector, but has, historically, been too complicated to measure and be utilized on a routine basis. A newly developed digital technique could change this.

In applying a visually clean standard, any residue related to the cleaning process that is visible on the surface should constitute a failure.

A new Good Automated Manufacturing Practice (GAMP) guide on IT Infrastructure Control & Compliance was launched in Chicago (IL, USA) 23 August 2005.1 The guide is intended to support pharmaceutical companies in their effort to establish a well-defined and compliant infrastructure. This article discusses different aspects of the guide that may support your organization in getting — and keeping — your infrastructure under control.

Exploring a simple and systematic approach to validating an FMS.

OTC Eye-Drop Maker Signs Consent Decree

American Pharmaceutical Partners to Merge with American BioScience

This week, the US Food and Drug Administration posted an Oct. 20 Warning Letter (http://www.fda.gov/foi/warning_letters/g5567d.htm) sent by its Minneapolis, MN district office to Diversified Manufacturing Corporation (Newport, MN).

CDER 2005 Product Approval Totals Proposed CDER Reorganization