Comparison of the Identified Maturity Attributes to the Requirements of ICH Q10
| Identified Maturity Attribute | ICH Q10 |
|---|---|
| Management Communication that Quality is Everyone's Responsibility | Section 2.1: Management Commitment (a) Senior management has the ultimate responsibility to ensure an effective pharmaceutical quality system is in place to achieve the quality objectives, and that roles, responsibilities, and authorities are defined, communicated and implemented throughout the company |
| Site has formal quality improvement objectives and targets | Section 2.2 Quality policy and 2.3 Quality Planning |
| Clear performance criteria for feedback and coaching | Section 2.4 Resource Management Management should determine and provide adequate and appropriate resources (human, financial, materials, facilities and equipment) to implement and maintain the pharmaceutical quality system and continually improve its effectiveness (b) Management should ensure that resources are appropriately applied to a specific product, process or site |
| Quality topics included in at least half of all hands meetings | Section 2.5 Internal Communication a) Management should ensure appropriate communication processes are established and implemented within the organization (b) Communications processes should ensure the flow of appropriate information between all levels of the company |
| Collecting error prevention metrics | Section 4. Continual improvement of the pharmaceutical quality system |