Quality Systems

FDA is juggling momentous changes, including new leadership and the proposed transfer of oversight for therapeutic biotech drugs.

Calibration management systems can lead to cost-effective global compliance when coupled with advances in information technology.

An all-electronic validation can provide storage costs savings and ensured document legibility.

The security of documents in the pharmaceutical industry has become a critical issue since the advent of electronic data transfer. Companies in Europe must comply with 21 CFR Part 11 if they sell in the US. The regulations also require that secure, computer-generated, time-stamped audit trails are used to record the date and time of operator entries and actions that create, modify or delete electronic records. In particular, the record change must not obscure previously recorded information.

Part II of this article describes the installation, operational, and performance qualification of an autoclave and discusses a system for change control.

The benefits of using computers and electronic records are proven in most fields of modern-day work, none more so than in laboratories. The opportunities for automation have improved productivity; the computational abilities have increased the accuracy of scientific data and allowed previously difficult or impossible analytical techniques to become routine affairs. This, in turn, has led to huge advances in drug discovery and in the chemical, biochemical and physical analysis of drugs and patients.

A limit test using ion mobility spectrometry (IMS) has the potential to dramatically reduce the time required for cleaning verification and cleaning method development. The traditional approach to cleaning verification, often using HPLC, is relatively resource intensive and can lead to significant delays in reporting results. The main advantage of IMS is that results are seen virtually instantaneously, so any necessary re-measurement can be done very quickly. If the results demonstrate cleanliness, production can resume in a matter of hours not days.

Indecision and incoherence in Brussels is leading to major concerns regarding the development of medicines in the EU. Political conflicts and lack of co-ordination on topics such as cancer research, stem cells and genetically modified animals have added to the air of uncertainty concerning the future conditions for the European pharmaceutical industry. And while European politicians, officials and researchers continue to squabble, people in developing countries requiring urgent access to drugs continue to go without essential treatment.

Part I of this article discusses examples for cycle types used in moist heat sterilization, parameter requirements for a standard cycle as defined by pharmacopeias, methods used to design sterilization cycles, and various approaches used to measure the efficiency of the sterilization process.

Congress debates legislation for a Medicare drug benefit while the industry expresses concerns about import control, drug counterfeiting, and patent rights.

In response to increasing concern about drug safety, FDA has implemented several administrative and policy changes, inclduing the new Office of Pharmacoepidemiology and Statistical Science and a renewed focus on risk assessment.

To fund expanded FDA operations designed to streamline drug development and approval, FDA and industry representatives have negotiated the Prescription Drug User Fee Act III.

Following a step-by-step approach to software development involves planning, analysis, construction, and implementation.

A new set of proposed GMP standards for excipents may present more problems than benefits.

Brand and product security technologies offer pharmaceutical manufacturers anticounterfeiting solutions.

FDA cites manufacturing difficulties as a main contributing factor to recent drug shortages, which mainly involve injectibles and vaccines.

Near-infrared spectroscopy is a sophisticated and selective technique that has emerged as a powerful tool for the analysis of pharmaceuticals.

Proposed funding increases for FDA reflect plans to significantly increase user fees collected from manufacturers under the Presciption Drug User Fee Act.

This study investigated the effectiveness of the direct extraction of tablets and shaking time on the disintegration of tablets, solubilization, and recovery of ibuprofen from tablets of various formulations, strengths, and spiked placebo.

FDA's Center for Drug Evaluation and Research is driving efforts toward creating initiatives to streamline regulatory processes, speed up drug production, and reduce costs.

Participants at a Pharmaceutical Research and Manufacturers of America workshop share their views about the acceptable analytical practices of conducting forced degradation studies.

Pharmaceutical companies will face a number of issues and challenges this year that will affect their resources, operations, and the markets they serve.

Anthrax contamination has put pharmaceutical quality and supply issues on the front page, along with patent and pricing policies.

Batch SCADA systems are assessed for regulatory compliance and functionality.