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In this RMMs & Environmental Monitoring In-Depth Focus: The rapid microbiological methods revolution; Controlling contamination in the pharmaceutical industry; Rapid Micro Methods Roundtable...
20 August 2013 | By Richard Hayes, Continuous Improvement Manager, Rottapharm
From their headquarters based in Monza, Italy, Rottapharm’s long history of success began in 1961 with the creation of a small laboratory for independent research. The company from its early beginning has continuously invested in research, innovation and development of pharmaceutical products for distribution on a worldwide scale. After acquiring…
Read the free digital version of the June / July edition of European Pharmaceutical Review magazine...
13 June 2013 | By Michael J. Miller, President, Microbiology Consultants, LLC and rapidmicromethods.com
This is the second paper in our continuing series on Rapid Microbiological Methods (RMM) that will appear in European Pharmaceutical Review during 2013. As the editor for the Encyclopedia of Rapid Microbiological Methods, I provide a summary of the latest volume, which was published earlier this year. New case studies,…
This year marks the 10th anniversary of the introduction of the International Conference on Harmonisation (ICH) guidance on stability testing of new drug substances and products (ICH Q1A(R2)) and the ancillary guidance on storage conditions (ICH Q1F). In 2003, the pharmaceutical industry thought that it had achieved its goal of…
18 April 2013 | By Radhakrishna S. Tirumalai
For sterile as well as nonsterile pharmaceutical products, manufacturers must eliminate or minimise potential risks to patients as well as product quality. While many contributing factors may affect the quality of a medicine or its ingredients, microbial contamination control and proper sterilisation methods are critical considerations for the manufacturer throughout…
18 April 2013 | By Heike Gottschalg, Rüdiger Gössl, Holger Memmesheimer and Holger-Thorsten Steinführer, Boehringer Ingelheim Pharma GmbH & Co KG
The principles of the application of Quality by Design (QbD) in the pharmaceutical industry in terms of development, manufacturing and control are well defined and described in the ICH guidelines Q8, Q9 and Q10. These guidelines mainly focus on the quality of the drug products, their manufacturing processes and the…
18 April 2013 | By Pascal Furrer, Pharmacist
Active substances are rarely administered alone. For example, levothyroxine, a synthetic form of the thyroid hormone, indicated in the treatment of hypothyroidism, is administered at a very low dosage, ranging from 15 μg to 200 μg. These very small amounts of powder mean that it is not possible to manufacture…
8 April 2013 | By TSI Inc.
This webinar provides an overview of different Rapid Microbiological Methods (RMMs) that can be used for environmental monitoring, their applicability and their pros and cons...
3 April 2013 | By BD Diagnostics
This webinar discussed how the validation of rapid methods continues to be an obstacle to greater adoption of these technologies.
21 February 2013 | By Michael J. Miller, President, Microbiology Consultants, LLC, Silvia Fragoeiro, Ananthi Ramachandran and Paul van Empel MSD Animal Health
This is the first paper in our continuing series on Rapid Microbiological Methods (RMM) that will appear in European Pharmaceutical Review during 2013. Flow cytometry represents one of a variety of viability-based RMM technologies that are currently available to the pharmaceutical industry. In flow cytometry, individual particles are counted as…
This article discusses how the pharmaceutical industry can leverage its competencies in outsourcing to accelerate time to market, improve quality and increase innovation at all stages of the drug discovery and development process. The pharmaceutical industry is being battered by a perfect storm of not just one but three major…
Founded in 1991, AMRI (Albany Molecular Research Inc.) is a contract research and manufacturing organisation, with locations in the US, Europe and Asia. The company provides fully integrated drug discovery, development and manufacturing services to the pharmaceutical and biotechnology industries.
In this Pharmaceutical Manufacturing & Packaging In-Depth Focus: The chemical safety assessment process for extractables and leachables associated with packaged pharmaceutical products; INTERPHEX 2013: Show preview...
5 February 2013 | By Abzil BioVigilant
This webinar offers insight from both an end user and a supplier in order to share with you compelling reasons to consider the use of RMMs to gain a better understanding of your environment while improving your competitive advantage...
