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May 01, 2004
Current microbiological methods cannot measure microbial contamination at the levels that engineers and regulators seek to establish for aseptic processing cleanrooms. New approaches for assessing data and establishing alert and action levels are advocated, and an example of one analytical tool is considered.
March 01, 2004
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.
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.
February 01, 2004
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.
January 01, 2004
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.
December 01, 2003
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.
The importance of calibrating instruments used in manufacturing processes is well known, particularly for highly regulated industries such as pharmaceutical production. This article discusses software applications used to support calibration management, and the potential economic gain to be had by replacing a standalone software application with a capable enterprise system.