Quality Systems

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

The International Organization for Standardization (ISO, www.iso.org) has approved the use of the photometric method for liquid delivery performance verification. Artel (Westbrook, ME, www.artel-usa.com), a manufacturer of precision testing and calibration systems for liquid handling instruments, uses the photometric method to calibrate pipettes and automated liquid handlers.

11 Universities Join FDA ?National Institute for Pharmaceutical Technology and Education?

New FDA Guidance on Electronic Common Technical Document Submissions

US District Court Rejects FDA Suit to Block Device Manufacturer

"It was just after FDA had initiated the Pre-Approval Inspection process," reports our GMP Agent-in-Place.

New leadership must address political and scientific issues as the Medicare drug benefit alters manufacturer incentives.

Moheb Nasr, PhD, director of the newly created Office of New Drug Quality Assessment at the US Food and Drug Administration (Rockville, MD, www.fda.gov), has proposed creating a "regulatory agreement" between FDA and sponsors to govern the chemistry, manufacturing, and controls (CMC) sections of new drug applications (NDAs).

This article provides a PhRMA perspective and recommendations on an FDA guidance currently under development dealing with postapproval changes after the final intermediate of the active pharmaceutical ingredient, i.e., BACPAC II. The concept of a "last true solution" is proposed as an additional point in the assessment of potential risk associated with process changes.

The extensible markup language (XML) format facilitates compliance with FDA's new requirements for prescription drug labeling submissions, improves patient safety, and enhances manufacturing sponsor efficiencies.

Information technology can streamline compliance and increase operational efficiency and quality.