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Application note: USP <643> TOC limit changes
This application note addresses the TOC limit changes in USP for packaged water. The new limits account for varying container volumes.
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Good Manufacturing Practice (GMP)
Good manufacturing practices (GMP) are the practices required in order to conform to the guidelines recommended by agencies that control authorisation and licensing for manufacture and sale of drug products and active pharmaceutical products. These guidelines provide minimum requirements that a pharmaceutical manufacturer must meet to assure that the products are of high quality and do not pose any risk to the consumer or public.
![Researcher looking at an experiment [Credit: Unsplash].](https://www.europeanpharmaceuticalreview.com/wp-content/uploads/Bell-advanced-therapies-feature-300x278.jpg)
![Researcher looking at an experiment [Credit: Unsplash].](https://www.europeanpharmaceuticalreview.com/wp-content/uploads/Bell-advanced-therapies-feature.jpg)
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UK at the forefront of advanced therapies
Advanced therapies are a ground-breaking new class of medicines that use gene therapy, cell therapy or tissue engineering to treat disease and injury. Rachel Bell, Trainee Patent Attorney at Marks & Clerk, and Ceri Roberts, Scientific Training Manager – Cellular and Molecular Therapies at NHS Blood and Transplant, discuss some…
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Worksheet: ARMM technology comparison
This worksheet can be edited to include specifications discovered during your evaluation of Alternative Rapid Microbiological Method Technologies.
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Whitepaper: How digital modelling supports cleanroom design
In this whitepaper, C2C’s Product & Process Development Lead explains how using digital modelling in the design process can guarantee results.
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Scientific briefing: Formulation-Monodisperse CR quetiapine microspheres
Adare’s Optimµm® technology offers a unique and efficient method of fabricating monodisperse microparticles at reduced development time.
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On-demand webinar: The art of changing QC testing methods
Learn how you can go about changing QC test methods and how this can go a long way to helping your lab achieve data integrity compliance.
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Improve efficiency and return on investment by adopting molecular spectroscopy techniques in pharma manufacturing
3 August 2021 | By Thermo Fisher Scientific
In this on-demand webinar, discover the differences between FTIR, NIR and Raman spectroscopy, learn how spectroscopy is applied in quality control labs and hear how implementation of these techniques increased efficiency and minimised costs.
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Whitepaper: Cleaning validation
This whitepaper discusses cleaning validation and the considerations required for a successful outcome.
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Scientific briefing: Formulation of aqueous core poly (lactic acid) microcapsules
Using a proprietary Stratµm TM technology, we have created 50 µm capsules with an aqueous core and thin PLA shell.
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FDA suggests principles for implementing bio-fluorescent particle counters
FDA provides guidance on the validation and regulations for bio-fluorescent particle counting technology as an alternative, continuous method for bioburden testing in air and water systems.
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Rabbit pyrogen test to be replaced by European Pharmacopoeia
The European Pharmacopoeia will put an end to the rabbit pyrogen test in the next five years and encourages industry to adopt the monocyte-activation test instead.
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Scientific briefing: Dissolution development Parvulet technology with oral tablets
Parvulet™ Technology is a patented oral dosage form capable of being dispensed to patients in tablet or powders, and converted into a semi-solid with water.
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Whitepaper: Digital transformation of medical devices sterilisation by EtO
A new perspective of digital transformation in a terminal sterilisation process of medical devices such as syringes used for Covid-19 vaccination.
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Manufacturing, Packaging & Logistics In-Depth Focus 2021
In this in-depth focus, find out about the key points to consider when implementing new software in the pharma development space and the current positions of the EMA and FDA with regards to nitrosamine contaminants.
