Quality Systems

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.

Coordinating validation efforts throughout an organization requires an accurate and timely overview and a validation master plan (VMP).

Risk analysis and evaluation of software and computer systems is a good tool to optimize validation costs by focusing on systems with high impact on both the business and compliance.

The EU ATEX Directive 1999/92/EC (ATEX 137) regarding the minimum requirements to protect the health and safety of workers potentially at risk from explosive atmospheres came into European law in January 2000. In the UK, the ATEX 137 Directive has been implemented as part of the Dangerous Substances and Explosive Atmospheres Regulations (DSEARs), which were issued in December 2002.

Performing studies to mathematically 'correlate' swab and rinse sampling values does not add any value. What's more, do not expect them to mathematically correlate.

FDA's Evans Reviews Causes of Warnings and Recalls

Patheon, CEPH Begin Corrective Action Program for Omnicef OP

USP Announces Monograph Revisions List and Postponed Publication of General Chapter <1226>

FDA Proposes New CMC ?Regulatory Agreement?

CEPH International Replies to FDA Warning Letter

CDER Creates Office of New Drug Quality Assessment