Product Process Understanding

Quality by Design

Product Process Understanding (PPU) is the knowledge and control of process variables and materials to optimize customer value by aligning the voice of process to the voice of customer. This approach results in improved product performance, target alignment and reduced variation, giving you peace of mind that quality is designed into your product and its manufacturing process.

At 3M, PPU is how we do business and aligns with FDA expectations for Quality by Design.

Quality Systems

3M has quality systems in place to ensure products are designed and produced to meet or exceed customer requirements. These systems are developed using a cross-functional approach utilizing a number of internal “scorecards” to assess our manufacturing process in real time and take proactive actions to maintain our goal of continuous improvement.

Regular Self Audits

• FDA cGMP compliance
• MHRA compliance
• ICH Q8 (Pharmaceutical Development), ICH Q9 (Risk Management), and FDA Quality Systems

Approach to cGMP

• Global electronic systems for Issue Management (eg, Corrective Action Preventive Action (CAPA), complaints) promotes:
  • Issue visibility
  • Root-cause analysis and speed to resolution
• Quality control laboratories at each site
  • Raw materials, in-process and final product release
  • Microbiological testing
  • Stability testing
• Accredited quality professionals