The QMN Weekly Bulletin

ICH Q10 Emphasizes Management Responsibility for Quality Systems

July 20, 2007

The International Conference on Harmonisation’s (ICH) new Q10 guidance emphasizes management’s responsibilities for a firm’s pharmaceutical quality system, including oversight and review of outsourced activities.

“Senior management has the ultimate responsibility to ensure an effective pharmaceutical quality system is in place, and that responsibilities and authorities are defined, communicated and implemented throughout the company,” the guidance states.

Management’s responsibility extends to participation in the design, implementation and monitoring of the system, and support for appropriate resources, the guidance says. In addition, its responsibility extends to implementation of an effective communication and escalation process to raise quality issues to the appropriate levels of management.

Oversight of outsourced activities, such as repackaging and contract manufacturing, are also included. “The contract giver should be responsible for assessing the suitability and competence of the contract acceptor to carry out the work required. Responsibilities for quality-related activities of the contract giver and contract acceptor should be specified in a written agreement,” the guidance states.

The guidance also says that ICH Q10, when used in conjunction with ICH Q9, provides regulators with the opportunity to increase the use of risk-based inspections and to “optimize science and risk-based postapproval change processes to maximize benefits from innovation and continual improvement.”

The guidance can be accessed at