Recent Regulatory Trends in Pharmaceutical Manufacturing and their Impact on the Industry.

The pharmaceutical industry is one of the most regulated industries in Switzerland. Though the concept of good manufacturing practises (GMP) was implemented for chemical production in the early 1990s, the rules and regulations for our industry are in constant evolution. In this article we will highlight the impact of these changes to the industry using three recent guideline up-dates as examples: the implementation of ICH Q3D 'Guideline for elemental impurities', the EU-GMP Guideline Part III Chapter 'Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities' from 01. June 2015, and the new guidelines to data integrity such as 'PIC/S 041-1 Good Practices for Data Management and Integrity in regulated GMP/GDP environments'. These examples show how scientific approaches help to modernize the control strategies for our products and increase product quality for a better patient safety. The requirements of data integrity regulations are also of interest to industries and universities not working under GxP requirements as they also support the business to improve data quality (traceability) for patent applications, and reduce risk of data falsification.

Element analysis of small and even smaller objects by ICPMS and LA-ICPMS.

Inductively coupled plasma mass spectrometry is increasingly used for non-traditional applications such as the analysis of solids at high spatial resolution when combined with laser ablation or the analysis of engineered nanoparticles. This report highlights recent projects and discusses the potentials and limitations these techniques offer. High-resolution laser ablation instrumentation allows element imaging at the µm-scale and can, therefore, be applied to, e.g., the mapping of metal isotope-labeled antibodies in biological tissues. Despite these advancements, the quantitative analysis of laser-produced aerosols is still a major concern. Here, the accuracy of analysis was found to strongly depend on particle size distribution but also on the morphology and composition of particles. In order to achieve a controlled supply of nanoparticles for analysis by inductively coupled plasma mass spectrometry, a dedicated microdroplet injection system was developed and characterized. This system allows a reproducible injection of single nanoparticles together with internal standards to determine their mass and composition.