The requirements of good manufacturing practice are underpinned by a central objective: to create a system of programs, policies, processes, and facilities that prevent errors and defects. Senior managers in the drug industry are responsible for the effectiveness of this system, which is known as the Pharmaceutical Quality System (PQS). A PQS is successful when it assures an ongoing state of control. In a healthy PQS, managers establish a vigilant quality culture in which timely action is taken to prevent risks to quality. Lifecycle adaptations are made to address manufacturing weaknesses and continually improve systems. An effective process performance and product quality monitoring program provides early warning of emerging quality issues. Systemic solutions are implemented rather than ineffective shortcuts. A firm will also habitually attend to the seemingly small problems that quality experts remind us later would accumulate into costly, complex problems. An effective PQS will ultimately support stable processes, and predictable quality and supply.
Upcoming Relevant Conferences/Meetings
- FDA and Parenteral Drug Association (PDA) Joint Regulatory Conference, September 8-10, 2014, Washington, D.C. Meeting Information
Quality Systems Inspections
- ICH Q10 Pharmaceutical Quality Systems (Guidance for Industry, April, 2009)
- Quality Systems Approach to Pharmaceutical CGMP Regulations (Guidance for Industry, September, 2006)