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QA / QC - Articles and news items
Supplier news / 26 October 2016 / Cobalt Light Systems
The United States Food and Drug Administration (FDA) has purchased Cobalt’s TRS100 transmission Raman instrument for use by the Division of Pharmaceutical Analysis (DPA)…
Lonza to Hold Free Webinar on LIMS and MODA-EM™ Solution – A Comprehensive Solution for Pharmaceutical Manufacturing Quality Control
Supplier news / 20 October 2016 / Lonza
Lonza will hold a free 60-minute webinar on 2 November 2016 titled “LIMS and MODA-EM™ Solution – A Comprehensive Solution for Pharmaceutical Manufacturing Quality Control”…
Supplier news / 22 March 2016 / Cherwell Laboratories
New 2016 Redipor® price list available on request…
Historically, dissolution testing has been used primarily as a quality control (QC) test for solid oral drug products . Indeed, it is the only QC test which provides a measure of the quantitative release rate of the drug from the pharmaceutical product. More recently, the test has been proposed in lieu of bioequivalence testing. However, can the same dissolution test have enough robustness (as per 5 ) to be used as a routine QC tool, whilst simultaneously being sensitive enough to be truly bio-predictive? This article will explore this conundrum…
Issue 1 2016 / 29 February 2016 / SOTAX Group
There are several sources of variability in the “inherently poor design” of compendial dissolution apparatus types. Nevertheless, dissolution testing is a QC requirement for many products, and so the industry faces the challenge of implementing and managing fleets of dissolution equipment. However, through instrument and process design and automation, managing the products, equipment, and personnel associated with routine QC testing can be streamlined…
Whitepapers / 15 January 2016 / Dr. Matthias Wagner, Product Manager, Mettler Toledo
Heated crystalline pharmaceutical compounds undergo morphological changes that can be observed under a microscope. With hot-stage microscopy changes in melting points and ranges or crystallisation can be visualised for research and QC purposes in order to influence drug stability or effectiveness…
Supplier news / 12 January 2016 / DiscoveRx
DiscoveRx Corporation announces the expansion of its PathHunter® cell-based assays portfolio with the release of PathHunter Interleukin cell-based assays…
The rapid microbiological methods revolution.
Controlling contamination in the pharmaceutical industry.
Rapid Micro Methods Roundtable.
Whitepapers / 15 July 2013 / Katherine A. Bakeev and Robert V. Chimenti, B&W Tek
Understand the pros and cons of using correlation versus multivariate algorithms for material identification via handheld spectroscopy…
Hot topics in rapid methods: revisions to validation guidance and real-time environmental monitoring
This is the sixth and final paper in our continuing series on Rapid Microbiological Methods (RMM) that have appeared in European Pharmaceutical Review during 2012. As many of you already know, I am keen on staying on top of recent developments in the world of rapid methods, and have used my own blog (http://blog.rapidmicromethods.com) to communicate technology advances and changes to regulatory and validation practices and expectations. In my final article of the year, I am providing an overview of two very interesting topics that have sparked additional discussions within the professional community: the proposed changes to USP’s informational chapter on the validation of alternative microbiological methods and real-time environmental monitoring.
Revision to USP Chapter <1223>: Method validation is the process used to confirm that an analytical procedure employed for a specific test is reliable, reproducible and suitable for its intended purpose. All analytical methods need to be validated prior to their introduction into routine use, and this is especially true for novel technology platforms such as RMMs.
Because many RMM technologies consist of a combination of instrumentation, software, consumables and reagents, in addition to specific detection, quantitative or identification methodologies, it is important to develop a comprehensive and holistic approach to the validation process to ensure that the entire RMM system is suitable for its intended use.
ABB Analytical Measurement ACD/Labs ADInstruments Ltd Advanced Analytical Technologies GmbH Analytik Jena AG Astell Scientific Ltd B&W Tek Bachem AG Bibby Scientific Limited Bio-Rad Laboratories BioNavis Ltd Biopharma Group Black Swan Analysis Limited Charles Ischi AG | Kraemer Elektronik Cherwell Laboratories CI Precision Cobalt Light Systems Coulter Partners CPC Biotech srl Dassault Systèmes BIOVIA DiscoverX Edinburgh Instruments Enterprise System Partners (ESP) EUROGENTEC F.P.S. Food and Pharma Systems Srl IDBS JEOL Europe L.B. Bohle Maschinen + Verfahren GmbH Lab M Ltd. LabWare Linkam Scientific Instruments Limited Molins Technologies Multicore Dynamics Ltd Nanosurf New England Biolabs, Inc. Panasonic Biomedical Sales Europe B.V. PerkinElmer Inc ReAgent Russell Finex Limited Source BioScience Takara Clontech Tornado Spectral Systems Tuttnauer Watson-Marlow Fluid Technology Group Wickham Laboratories Limited Xylem Analytics YMC Europe GmbH Yusen Logistics