Quality Systems

The renewal of European regulations regarding pharmaceutical process validation in autumn 2001 has been the subject of much discussion. The purpose of this article is to summarize and review the development of pharmaceutical process validation, and demonstrate how industry opinion regarding the concept has shifted from that of a regulatory burden to something driving total quality management and cost benefits.

Health experts are recognizing teh need to plan for global manufacturing of new treatments for AIDS and other diseases.

Pharmaceutical science & technology news.

Analytical methods development and validation play important roles in the discovery, development, and manufacture of pharmaceuticals. The official test methods that result from these processes are used by quality control laboratories to ensure the identity, purity, potency, and performance of drug products.

Brussels report

Progress in developing AIDS vaccines is focussing attention on the challenges involved in producing millions of doses for developing nations.

Bridging the gap between compliant spreadsheet production and limitations in available technology can be achieved by the use of custom-created electronic solutions.

A procedures system must be well designed and managed to be effective and efficient.

Brussels report

It has been demonstrated that the existing FDA dose content uniformity test has very poor statistical relevance, which has resulted in the acceptance of poor quality batches and the rejection of good quality batches. By using Bayesian Inference, a much improved test has been produced that allows the quality of a batch of drug product to be determined accurately, using a suitable number of samples for the quality of the batch.

India's pharmaceutical industry, which is one of the country's major economic sectors, is poised to make signficant gains on the global market.

Efforts to establish a Medicare pharmacy benefit programme will affect drug pricing and policies that shape industry research and development.

Reform legislation about generic drugs remains at the forefront of debate as innovator companies poise to challenge FDA proposals regarding patent laws.

December's Contract Services articles include "Using Virtual Private Networks to Gain Competitive Advantage," by Mark Tuomenoska and "Outsourcing Outlook," by Jim Miller.

Spectroscopy using light is a familiar technique and the electromagnetic spectrum from UV to IR is routinely employed. This article looks at the advantages and applications of spectroscopy using sound waves, with special reference to pharmaceutical research.

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.