A risk-based approach to compliant GxP Computerized Systems.

The pharmaceutical industry is responding to the challenge of significantly improving the way drug development and manufacturing is managed.

New concepts are being developed and applied, including science based risk management approaches, a focus on product and process understanding, and the application of Quality by Design concepts.

Many of these ideas are defined and described in the FDA 21st Century Initiative, new ICH documents such as Q8 Pharmaceutical Development, Q9 Quality Risk Management and Q10 Pharmaceutical Quality System, ISPE’s Product Quality Lifecycle Implementation (PQLI) initiative, and various supporting industry consensus standards, such as the ASTM E2500 Standard Guide for Specification, Design and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment.

Drivers for GAMP 5:

  • Focus on Patient Safety, Product Quality and Data Integrity
  • Effective Governance to Achieve and Maintain GxP Compliance
  • Quality Design
  • Continuous Improvement within QMS
  • Critical Quality Attributes (CQA)
  • Improving GxP Compliance Efficiency
  • Configurable Systems and Development Models
  • Use of Existing Documentation and Knowledge
  • Effective Supplier Relationships
  • Scaleable Approach to GxP Compliance
  • Science Based Quality Management of Risks
  • Life Cycle Approach within QMS
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