FDA's Guidance on Pharmaceutical Quality System

• By: Staff Editor
• Date: May 16, 2017
• Source: www.fda.gov

FDA's Guidance on Pharmaceutical Quality System

The US FDA, in April 2009, has announced the availability of the ICH Q10 guidance on the pharmaceutical quality system. This guidance along with the ICH “Q8 Pharmaceutical Development” and ICH “Q9 Quality Risk Management” are essential for implementing an effective pharmaceutical quality system.

This guidance applies to pharmaceutical drug substances and drug products, including biotechnology and biological products, throughout the different stages of a product lifecycle. The scope of guidance outlines the major components of product lifecycle as:

• Pharmaceutical Development: Drug substance development, formulation development, manufacture of investigational products, delivery system development, manufacturing process development and scale-up and analytical method development.
• Technology Transfer: New product transfers during development through manufacturing, and transfers within or between manufacturing and testing sites for marketed products.
• Commercial Manufacturing: Acquisition and control of materials, provision of facilities, utilities, and equipment, production , quality control and assurance, release, storage, and distribution.
• Product Discontinuation: Retention of documentation, sample retention, and continued product assessment and reporting.

Key Focus Areas

The guidance addresses several key areas of focus, such as relationship of ICH Q10 to regional GMP requirements, ISO standards, and ICH Q7; ICH Q 10 objectives; design and control considerations; management responsibilities; pharmaceutical quality system elements; continual improvement of the pharmaceutical quality system and more.