New guidelines are elaborated and established guidelines have to be revised to take into account the scientific and technological progress in the pharmaceutical industry. The ICH Q12 Guideline is currently in the international implementation phase and will impact massively product development, dossier preparation, variations and product transfer activities. ICH Q14 has been drafted to set standards for the development of analytical methods and is closing a gap which has been opened with the implementation of ICH Q8 Pharmaceutical Development. As a consequence, the old ICH Q2 Guideline on Analytical Validation had to be revised taking into account new analytical techniques
and their validation. Continuous manufacturing is increasingly implemented for high volume pharmaceutical manufacturing and after almost 10 years lack of clarity what documents will be required by the authorities and how process validation should be designed, the ICH Q13 draft provides guidance to industry and authorities.
For companies active in the EU, it is important to closely follow up the publications of the EMA.
In summary, this course will help the delegates to identify important new GMP and Regulatory aspects which should be considered throughout the entire life cycle of their specific products and avoid waste of time and money, thereby.