Polymeric materials in manufacturing processes: a new theat of extractable impurities

1. Introduction In the last few years, elastomer, thermoplastic or thermostable plastic polymeric materials have become established as basic components in many pharmaceutical and biotechnological manufacturing processes. The range of polymeric materials available in the industry is very broad and materials have been developed with very different structural properties depending on the desired application. Some…

Accessing the European Pharma Market: becoming a MAH through dossier adaptation (II)

The European pharma market is becoming more competitive and accessible through its effort to adopt globally acknowledged standards and requirements, it is not surprising the increasing interest of investors to this appealing market. When a non-European company is considering investing in EU business opportunities different strategies may be implemented depending on the company needs. One…

RESIDUAL SOLVENTS IMPURITIES. ICH Q3C

Introduction Solvents used in pharmaceutical industry are generally volatile organic compounds that are involved in many processes of both synthesis and purification of APIs, excipients and medicines. Their use is essential given that, in many cases, they allow to improve yields and selectivities of the processes, facilitate purification stages and even they lead to some…

Accessing the European Pharma Market: becoming a MAH through dossier acquisition.

  Positioned as the second largest pharmaceutical market in the world and showing a steady and extensive growth pattern, Europe’s pharma market is becoming increasingly attractive, but accessing this market implies both regulatory and technical requirements, so different strategies need to be considered to ensure cost-effectiveness. One of the options available for companies seeking to…

Extractable and Leachable Impurities

What is an extractable impurity? Depending on their chemical nature and migratory properties from the container to the medium, these types of organic or inorganic impurities originating from the packaging materials may be classified as extractables or leachables. Therefore, extractables impurities can be defined as compounds released by the material in extreme temperature conditions, exposure…