Validation

From WikiBioPharm

Validation, as defined by FDA's 1987 Guideline on General Principles of Process Validation, is "Establishing documented evidence which provides a high degree of assurance that a specific process will consistently produce a product meeting its pre-determined specifications and quality attributes."

Validation is a requirement of CGMP (Current Good Manufacturing Practices).

Contents 1 Topics 1.1 Qualification Types 1.2 Validation Types 1.3 Related Topics

Topics

Qualification Types

• Design Qualification (DQ)
• Installation Qualification (IQ)
• Operational Qualification (OQ)
• Performance Qualification (PQ)

Validation Types

• Process Validation (PV)

• Facility Qualification

• Computer System Validation (CSV)

• Equipment Qualification (EQ)

• System Qualification (see here for Utility Systems Validation)
• Cleaning Validation (CV)
• Methods Validation
• Packaging Validation (PkV)

Related Topics

• Validation Master Plan (VMP)
• System/Software Development Life Cycle
• Risk Assessment

• Validation Protocol

• Equipment and Materials