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European Pharmacopoeia (Ph. Eur.) - Articles and news items
Issue 1 2016 / 29 February 2016 / Dave Elder, GlaxoSmithKline and JPAG
Globalisation has facilitated greater international harmonisation and standardisation of quality standards, which in turn has impacted on pharmacopoeias. Historically, general chapters were developed based on input from local regions with little concern for global consequences. This often led to the development of similar, but unidentical tests, for example, Residue on Ignition (USP <281>) versus Sulphated Ash (Ph.Eur., 20414; JP, 2.4.44) . Similarly, pharmacopoeial monographs of active pharmaceutical ingredients (APIs) were developed primarily based on the input of the innovator and single sources of the API. In contrast, today’s monographs must reflect multi-source APIs from many generic suppliers, typically from India and China, rather than from Western Europe and the United States. Consequently, the test methods must be cheap, globally available and state-of the-art, but selective and robust – often a significant challenge…
Whitepapers / 15 January 2016 / Merck Millipore
The Milliflex® Quantum system (Merck Millipore) is a rapid method for the quantitative detection of contaminants in filterable samples…
Whitepapers / 15 January 2016 / HunterLab
Measurement and validation of the European Pharmacopoeia (EP) Colour scale…
From 2010 to 2013, European Pharmaceutical Review published a very successful series on rapid microbiological methods (RMM) that included hot topics such as the European Medicines Agency’s and US Food and Drug Administration’s expectations, implementation strategies, scientific principles behind the technologies and validation. The final article of the 2012 series introduced the United States Pharmacopeia’s (USP’s) plan to revise informational chapter <1223>, Validation of Alternative Microbiological Methods.1 On June 1, 2015, a substantially modified chapter <1223> was published in the second supplement to USP38/NF33 with an official date of 1st December 2015. Because the original USP chapter was published almost 10 years ago, this article will review the most notable changes and compare them with what is recommended in the Parenteral Drug Association (PDA) Technical Report Number 33 and the proposed revision to European Pharmacopoeia (Ph. Eur.) chapter 5.1.6…
Supplier news / 2 October 2014 / Hyglos
News from the European Pharmacopoeia…
The US Food and Drugs Administration (FDA) produced their guidance for industry on tablet scoring in March 2013 to ensure that tablet scoring (breakmarks or breaklines) on generic tablets would enable them to be split in the same effective way as their reference listed products (RLD). These breakmarks on tablets were originally developed to allow tablets to be split into two or four equal parts to help the ingestion of large tablets or to allow a reduction in dose, e.g. for children or the elderly. However, some generic drugs have included breakmarks just so that they look like the RLD without the breakmarks being functional. Thus, the FDA desired consistent scoring between a generic product and its RLD. There is also the problem of insurance comp – anies and doctors increasingly recommending that patients split high dosage tablets and take those halves or quarters to save money on their medicines bills. It is interesting that the FDA considers that tablet splitting is manufacturing under the Federal Food, Drug and Cosmetic Act and therefore establishments that do this must register with the FDA and comply with Current Good Manufacturing Practice (CGMP). However, this would not apply to a pharmacy dispensing a prescription for individually identified patients.
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.
MALS instruments represent the latest EP requirements for HES characterization….
This is the sixth and final paper in a series of articles on rapid microbiological methods that have appeared in European Pharmaceutical Review during 2010. Over the past year, we have explored the world of rapid microbiological methods (RMMs), focusing on validation strategies, regulatory expectations, and the technical and quality benefits of these novel systems as compared with conventional techniques. It should be obvious by now that RMMs will significantly impact the future of microbiology within the pharmaceutical and biotech industries. But don’t just take my word for it.
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