Excerpt from the GMP MANUAL
The ICH guidelines Q8, Q9 and Q10 represent the current thinking on the development of quality systems across the lifecycle of a product. While these guidelines are not binding, they trigger ongoing discussions to improve quality systems and procedures in the pharmaceutical industry. The knowledge of this comprehensive set of guidelines is therefore a must for every responsible person in the quality and GMP area.
- ICH Q8 Pharmaceutical Development
- ICH Q9 Quality Risk Management
- ICH Q10 Pharmaceutical Quality System
- Questions and Answers on Q8, Q9 and Q10