Quality Systems

This article discusses the basics of sterile filter qualification and validation, with emphasis on bacterial challenge protocol development and testing. Reference is made to Technical Report no. 26 of the Parenteral Drug Association.

FDA's recently released initiative has made process analytical technology (PAT) a hot topic in the life science industry. PAT describes the application of process analytical chemistry tools, feedback process control, information management tools, and product and process optimization strategies for the development and manufacture of pharmaceuticals. In this article, the author explores the impact PAT will have on the pharmaceutical industry.

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FDA is re-engineering the CMC review process for innovator and generic drugs and backing risk-based ICH quality standards.

Pharmaceutical Science & Technology News

A straightforward approach reveals how the probability of passing the USP content uniformity test can be calculated for tablets and capsules.

Particulate generation and durability concerns are encouraging pharmaceutical manufacturers to seek alternatives to wood pallets.

Customers are placing high demands on pharmaceutical manufacturers to produce sensitive, cost-effective and regulatory compliant inspection technology. This article examines how metal detection equipment suppliers can combine forces with manufacturers to provide state-of-the-art inspection systems, giving particular consideration to cleaning processes and regulatory issues.

This article investigates what defines a best-in-class QC lab based on experience of implementing operational improvement projects in world-class labs. It includes an assessment of a benchmarking process, a case study of improvements made as a result at one company and findings on what constitutes best-in-class for QC labs.

In Europe ... the onward rush of time has imposed no change at all during the last 25 years. Anyone could step back in at any point, at any moment, and find the same depressingly familiar debates, interminably failing to reach any real conclusions.

The author describes the efforts of the standards committees to establish guidelines for PAT implementation and the impact of the guidelines on the industry.

Pharmaceutical Science & Technology News

FDA's latest proposal focuses on electronic health systems for filing drug labeling information and facility and product data.

Although the United States Pharmacopeia-National Formulary is an everyday reference book, the people and processes behind it are not so familiar.

Most, if not all, pharmaceutical companies today are moving towards a paperless reporting structure. This article examines FDA's 21 CFR Part 11 regulations, which relate to technical and procedural compliance for electronic records and signatures.

Resolving the asset headache - the author explains how effective asset management can enable pharmaceutical companies to boost operational profit, increase production uptime and adhere to regulatory standards.

If an inspection reveals any shortcomings ... a manufacturer may be warned, fined, or its facility closed down until full control can be demonstrated to the satisfaction of the authorities ....

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.