Masterarbeit

Changes in the regulatory assessment of manufacturing process validation ***

Till Teschke (2016)

Summary
Language: English
In recent years, the concept of manufacturing process validation has changed considerably. Process validation used to be an isolated, one-time, and temporary activity. Today, process validation is seen as a series of activities which span a large part of the product lifecycle, and which are closely linked to other activities, such as development, and the maintenance of process confidence. In the past, process validation was also often mistaken for a mere documentation exercise. By contrast, process validation is now recognised as a key element of quality assurance.
These changes in the perception of process validation were caused by the strategic ICH guidelines Q8, Q9, and Q10. The objective of these guidances is to improve the quality of medicinal products and the efficiency of pharmaceutical manufacturing. Concepts from Q8, Q9, and Q10 had a strong influence on the new EMA guideline on process validation for finished products, which was adopted in February 2014. The influence of these concepts on several aspects of process validation is the main subject of this master thesis. One outcome, the enhanced process validation approach continuous process verification, has the potential to not only remedy the shortcomings of the past, but also to offer significant benefits to manufacturers, regulators, and consumers alike.
Pages: 39