The ICH Q10 - Pharmaceutical Quality System is a harmonized Guideline in USA, Europe and Japan and was approved in 2008. This Guideline applies to pharmaceutical drug substances and drug products, including biotechnology and biological products, throughout the product lifecycle. ICH Q10 is based on ISO 9000 structure with a pharmaceutical context emphasis on : management responsibility, improvement of quality system, and improvement of product quality over lifecycle.
The ICH Q10 Guidebook App presents ICH Q10 Guide in a user-friendly e-format. The users can easily reach to each section of guideline with customized view options. This is a convenient information and reference tool for all people working in pharmaceutical and biotech industry.
Keywords : ICH, Q10, Pharmaceutical Quality System, PQS, continual improvement, management responsibility, GMP, FDA, Regulation, Regulatory