Standards & Regulations

Nov 02, 2002
Pharmaceutical Technology
FDA is juggling momentous changes, including new leadership and the proposed transfer of oversight for therapeutic biotech drugs.
Nov 01, 2002
Pharmaceutical Technology Europe
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.
Oct 02, 2002
Pharmaceutical Technology
FDA is set to revise CGMPs to encourage new manufacturing technologies and develop improved agency policies to ensure drug quality and safety.
Oct 01, 2002
Pharmaceutical Technology Europe
By Albedo
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.
Oct 01, 2002
Pharmaceutical Technology Europe
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.
Oct 01, 2002
Pharmaceutical Technology Europe
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.
Sep 02, 2002
Pharmaceutical Technology
Congress debates legislation for a Medicare drug benefit while the industry expresses concerns about import control, drug counterfeiting, and patent rights.
Aug 02, 2002
Pharmaceutical Technology
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.
Jul 02, 2002
Pharmaceutical Technology
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.
Jun 01, 2002
Pharmaceutical Technology
FDA cites manufacturing difficulties as a main contributing factor to recent drug shortages, which mainly involve injectibles and vaccines.
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