FDA – New Quality Management System For The Pharmaceutical Industry

ICH Q10: final guidance for implementing an effective quality management system for the pharmaceutical industry.

The FDA has just issued its final guidance on ICH Q10.

This internationally harmonized guidance is intended to assist all pharmaceutical manufacturers by describing a model for an effective quality management system called pharmaceutical quality system. Based on International Organization for Standardization (ISO) quality concepts, it includes applicable good manufacturing practice (GMP) regulations, and complements ICH “Q8 Pharmaceutical Development” and ICH “Q9 Quality Risk Management.”

Interestingly, this model can be implemented throughout the different stages of a product lifecycle and strengthen the link between pharmaceutical development, manufacturing and commercial activities.

It reinforces the need for Leadership which is essential to establish and maintain a company-wide commitment to quality and for the performance of the pharmaceutical quality system to achieve product realization, to establish and maintain a state of control and to facilitate continual improvement.

FDA also insists that companies use knowledge and quality risk management and apply this guidance to their outsourced activities and the purchase of raw materials while conducting assessments of suppliers and service providers before entering into an agreement.