6523 After Mackey Validation of Biotech Facilities
6523 After Mackey Validation of Biotech Facilities
6523 After Mackey Validation of Biotech Facilities
Pacific Biotech Alliance is an established consulting firm in the Pacific Northwest that specializes in Biotech, Pharmaceutical, Medical Device and Diagnostic manufacturing, operations, facility construction & validation.
February 7, 2006
Orange Guide:
FDA Guidance
Aseptic Processing Guidance, Section IV Buildings and Facilities
Critical Areas (Class 100 ISO Class 5) Adjacent Areas (Class 10,000 ISO Class 7) Support Areas (Class 100,000 ISO Class 8) Clean Air Separation Air Filtration
Commissioning
Critical Vs. NonNon-Critical Product Contact Heavy Vs. Light Prelude to Qualification and Validation
Design
Optimize Material and Personnel Flow Equipment Placement and Flow Waste flow
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Design Qualification
User Requirements Design Specifications Verification of Design Parameters Support to Validation Calibration Certification
VP & RDS IQ, OQ, PQ, Requirements Traceability Matrix Validation Summary Plan
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Know cGxP (GMP, GLP, GCP, GEP) FDA Eases Phase I Manufacturing Requirements (See
Attached MS Word File)
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