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FDA's draft guidance on aseptic processing contains some inherent difficulties, including unrealistic expectations of sterility and microbial quantification, an absence of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.
FDA is expanding electronic data submission programmes to improve regulatory operations, and ensure appropriate and safe drug use.
Europe is debating the process by which drugs receive marketing authorization. As ever, the debating table features the EU, the pharmaceutical industry and the usual suspects among the European lobbies. The crux of the matter? Should comparative efficacy play a role in marketing authorizations?
In this article the authors examine a number of significant amendments to US policy regarding generic pharmaceuticals. These important changes could have a major impact not only on the US pharmaceutical market, but also globally. The US Food and Drug Administration (FDA) implemented new regulations, effective from 19 August 2003, that promise to benefit generic pharmaceutical companies in several ways. Significantly, they seek to prevent multiple 30-month stays and resolve much of the uncertainty regarding which patents may properly be listed in FDA's Orange Book.1,2
This article describes the use of a one-pot processor for the cleaning and cleaning validation of two drug compounds - water-soluble theophylline and water-insoluble mebendazole. Both substances were produced using wet granulation and microwave drying, after which the processor was cleaned using its clean-in-place (CIP) system. Swab samples were taken from areas considered critical during processing and analysed for remains of active ingredient. It was concluded from the results that the processor's CIP system is capable of removing both moieties to a level well within accepted regulations.
Pharmaceutical science and technology news
Pharmaceutical science and technology news
This month, readers are offered the opportunity to take part in a quiz. How many predictions from an old blueprint for the European pharmaceutical industry were correct? Remember, no cheating.
Based on a German initiative, an international standard on quality management systems for the primary packaging materials of medicinal products is discussed in this article. This new directive will help to standardize the production of primary packaging materials by defining global requirements.
Pharmaceutical science and technology news
FDA initiatives aim to spur the development of more-affordable treatments and ensure safe product use.
Pharmaceutical science and technology news.
This year has been one of tremendous activity at the US Food and Drug Administration (FDA) and other government agencies involved with health care, biomedical research and national security. Scientists completed sequencing the human genome, setting the stage for a period of important new medical therapy development. Efforts to protect the nation from biological warfare created pressures to produce new vaccines and medical treatments able to counter biological, chemical and radiological attacks (see sidebar "Combating bioterrorism").
When implementing computerized systems, it is important that both purchasers and vendors ensure that each stage of the process (from planning through operation to modifying) is properly validated. This article looks at some of the issues that arise when switching from traditional document-based procedures, and at the benefits that computerized systems can bring.
