Quality Systems

Pharmaceutical Science & Technology News

As FDA prepares for the Critical Path initiative, offices across the agency are expanding the use of the risk-based approach to regulation and applying a quality systems approach to internal operations.

Decisions to accelerate the approval of AIDS combination drugs, reject the over-the-counter status for the morning-after pill, and limit support for stem cell research are hot political topics.

Pharmaceutical Science & Technology News

The American society of Mechanical Engineers's Council on Codes and Standards has formed 10 subcommittees to update and broaden the scope of the BPE standards.

Congress is proposing legislation to legalize drug importing and holding hearings about emerging options.

A recent USP gathering generated creative suggestions for the March 2005 USP convocation.

The FDA guidelines that stipulate the conditions for starting materials are currently being superseded. PhRMA and several European pharmaceutical manufacturers have already added their voices to the ongoing discussion and, as this editorial explains, the debate is far from over. Rules are important, but industry is looking to a future when health care authorities are less inclined to impart total control over every aspect of production.

New technologies, along with changes in FDA oversight, may provide a critical path to make more new drugs available more quickly to patients.

Drug makers and their suppliers will need good planning and organization to meet the new bar coding requirements for drug products used in hospitals.

From data acquisition to enterprise resource planning, software systems operating at all levels of pharmaceutical manufacturing prepare for the seemingly inevitable implementation of process anlytical technology.

Pharmaceutical Science & Technology News

Total organic carbon (TOC) analysis is a fast and effective analytical technique for cleaning validation. Understanding the various types of TOC technologies is essential for choosing the best solution.

FDA expects a firm that is subject to GxP to develop a risk evaluation of its product and to then mitigate the identified risks. Identified risks may be addressed by technical fixes that effectively eliminate the risks or reduce the likelihood of occurrence and/or severity of consequences to acceptable levels.

What Medawar is calling for is "an overhaul of the secretive and profoundly inadequate system of medicines control," and hopes the unfolding crisis of dependency on antidepressants will prove to be a watershed.

FDA's draft guidance on aseptic processing contains some inherent difficulties, including unrealistic expectations of sterility and microbial quantification, an absence of harmonization with international rules, and failure to support new technologies or a risk-based approach. The authors propose a science-based alternative.

pharmaceutical science and technology news

Perils are perceived as pressing ever more intensely on the health of the evolving Europe. The reports of Europe's death may, however, be somewhat exaggerated.

FDA relies on e-chips to thwart bogus products, and drops paper pedigrees and unit-of-use packaging.

Pharmaceutical science and technology news

This article presents a simple and systematic approach to HPLC method development, beginning with sample preparation and finishing with practical analytical method validation.

Following the launch of its initiative, "Pharmaceutical cGMPs for the 21st Century: A Risk-Based Approach," FDA has been looking to process analytical technology (PAT) for improvements in process efficiency and quality. This article discusses the implementation of PAT systems into production environments, its impact on quality assurance and the necessity of an integrated approach. Options for implementing PAT are also presented.

The parallel importing battle continues between wholesalers and manufacturers. The two sides are slugging it out across member states, the courts and even in the streets of Brussels. The EU, meanwhile, has done what it does best - bury its head in the sand and hope that the whole thing blows over.

This article examines European differences in GMP requirements for the acceptance of Certificates of Tests. The authors look at how pharmaceutical manufacturers can address the issues and suggest a US-compatible framework for GMPs that could be incorporated into EU requirements.

FDA expands electronic data submission programs to improve regulatory operations and ensure appropriate and safe drug use.