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Validation
Validation
learngmp_admin
2021-12-31T00:02:21+00:00
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Validation/Qualification
Method
ICH Guideline for Analytical Method Validation
EMA-Validation of Analytical Procedures
FDA AP and MV for Drugs and Biologics
ASEAN Guidelines for Validation of Analytical Procedure
Process
FDA Process Validation General-Principles and Practices
EMA Guideline Process Validation
ASEAN Guidelines on Process Validation Scheme for Aseptically Processed Products.pdf
ASEAN Guidelines on Process Validation Scheme for Terminally Sterilised Products.pdf
Cleaning
FDA Cleaning validation 793
EMA Guideline SHBEL use Risk Identificatio .pdf
APIC Cleaning Validation Guide.pdf
Cleaning Validation 4
Computer System
FDA Guidance Documents / General Principles Software Validation
WHO Guideline Validation Computerized Systems Appendix5_QAS16-667.pdf
MHRA Computer System Validation
EU Guideline for Computer System validation.pdf
EDQM validation-computerized-systems-guideline
TGA computerised-systems-annex-11
Equipment
WHO Guidelines on Validation.pdf
EU Qualification and Validation.pdf
APIC Qualification existing Equipment.pdf
WHO Guidelines on Validation Appendix 6.pdf
Facility
WHO HVAC Systems Non Sterile Products TRS961 .pdf
GMP for HVAC Part 2 for Non sterile.pdf
ISO:14644: Guideline for Area Qualification
FDA Guidelines for Aseptic Manufacturing
Area Qualification 5
Area Qualification 6
HVAC System
WHO Supplementary Guidelines on GMP HVAC Systems Non Sterile Pharmaceuticals.pdf
GMP for HVAC Part 2 for Non sterile.pdf
HVAC System Qualification 3
Compressed Air System
ISPE Good Practice Guide.pdf
WHO Guidelines Validation Qualification Systems Utilities Equipment 673.pdf
Water and Steam System
WHO GMP Water Pharmaceutical Use TRS970 .pdf
FDA Inspection Guides High Purity Water System 793
ISPE Guidance Documents.pdf
EMA Guideline Quality Water Pharmaceutical-use.pdf
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