Qualification & Validation Compliance design qualification eu gmp

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Qualification and Validation (Q&V) are essential elements of Good Manufacturing Practices (GMP), ensuring that facilities, utilities, equipment, and systems consistently perform as intended and produce products of the required quality. Global regulatory agencies such as USFDA, EU-GMP, WHO, and MHRA require structured qualification and validation approaches aligned with GAMP 5 (Good Automated Manufacturing Practice) principles.

• Requires documented evidence that systems are suitable for their intended use.
   
• Validation must follow a lifecycle approach:
   
  • DQ (Design Qualification) – verifies design meets URS.
     
  • IQ (Installation Qualification) – checks proper installation.
     
  • OQ (Operational Qualification) – confirms system operates as intended.
     
  • PQ (Performance Qualification) – demonstrates consistent performance in real use.
     
• 21 CFR Part 11: For computerized systems, validation must ensure data integrity, electronic records, and audit trails.
   

• Annex 15 – Defines qualification & validation requirements for premises, utilities, equipment, cleaning, and process validation.
   
• Annex 11 – Focuses on computerized system compliance.
   
• Lifecycle validation and risk-based approach are emphasized.
   
• Change control and periodic review are mandatory.
   

• Emphasizes Q&V of HVAC, clean utilities, sterilization, and analytical methods.
   
• Requires risk assessment, documentation, and requalification at defined intervals.
   
• Stresses qualification of utilities such as WFI, PW, compressed air, and HVAC systems as part of facility validation.
   

• Follows EU-GMP principles, with added focus on data integrity.
   
• Requires computerized systems to comply with GxP data integrity guidance.
   
• Strong emphasis on audit trails, electronic signatures, and hybrid systems validation.
   

• Provides a practical risk-based approach to validation of computerized systems.
   
• Classifies systems into categories (from infrastructure to configurable/custom systems).
   
• Promotes critical thinking, risk management, supplier involvement, and lifecycle management.
   
• Aligns with regulatory expectations of USFDA, EMA, MHRA, and WHO.
   

While exact “percentages” are not defined in regulations, compliance expectation is interpreted as:

• USFDA & EU-GMP: 100% compliance required with validation lifecycle documentation and execution.
   
• WHO & MHRA: Full compliance with GMP and risk-based qualification approach.
   
• GAMP 5: Guidance framework – facilities aim for ≥95–100% compliance by applying risk-based, lifecycle validation for computerized systems.
   

• Develop Validation Master Plan (VMP) covering all systems.
   
• Maintain a complete document trail (URS, DQ, IQ, OQ, PQ, SOPs).
   
• Perform risk assessment (FMEA, HACCP) for prioritization.
   
• Establish change control & deviation management.
   
• Conduct requalification & periodic review to maintain compliance.
   
• USFDA – lifecycle validation, data integrity, Part 11 compliance.
   
• EU-GMP – Annex 15/11, risk-based approach, lifecycle documentation.
   
• WHO – utilities, equipment, and process validation with periodic requalification.
   
• MHRA – EU-GMP aligned with strong data integrity focus.
   
• GAMP 5 – framework for computerized systems validation.
   

All agencies demand a documented, risk-based, lifecycle approach to qualification & validation to ensure consistent product quality and patient safety.