GMP has long since become an important criterion for successful pharmaceutical and life sciences companies in China as well. Production for the west but also for China has to be GMP-compliant. The requirements are known in the meantime and must be observed and met in ongoing operation, but especially also in new construction projects.
Just as in Europe however, there is potential in regards to fault prevention, efficiency and the cost effectiveness of the chosen measures. That is why experienced consultants from gempex China Ltd offered two select presentations in the course of a GMP seminar, which was met with great interest by the participants:
Tips for efficient quantification & validation in new construction projects in the pharmaceutical industry
- Strategies for avoiding pitfalls
- Project schedules
- Engineering & qualification
- FAT/SAT activities
- Validation concept
- URS/risk classification
- Commissioning documents
Key principles for IT validation
- Product and process understanding
- Life cycle approach
- Scalable life cycle activities
- Quality risk management
- Leverage supplier involvement
Presented in the course of CPhI China*, the event was held directly at the exhibition site in Shanghai on 21 June 2018.