What is changing in Pharmaceutical world? How the new business model and the request of harmonization can impact the Pharmaceutical Business and the way to manage project?
The implementation of new rules to improve products quality & product Knowledge, increase product quality, harmonizes international standard requirements and requires evidence of Internal Knowledge from R&D to industrial process.
EMA Europe, as FDA USA, starts to apply PQLI principles so, Quality by Design Rules for Product development and Product changes, with direct impact on new Product Registration and variation.
A direct impact on the Region is due to Mexico and Brazil, which starts to apply restrictive inspection mechanism, new audit’s requirements for product, starting from the application of new restrictive GMP, up to specific Computer System Validation requirements.
To stay competitive in International Pharma Business, it’s necessary to follow the evolution of GMP and Validation Requirements, which make the International Rules of different countries even more similar, in terms of quality and controls.