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Useful site links and regulations for the life sciences industry
Pharmaceutical/Biopharmaceutical
Industry Links
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Regulations for Cleaning Validation and Ultrapure Water
APIC - Guidance for Cleaning Validation
cGMP - FDA Guidance on Quality Systems Approach
cGMP - 21CFR Parts 210-211
cGMP - FDA Guidance for the 21st Century
cGMP - FDA Guidance for Industry - PAT
cGMP - FDA Guidance on Investigating Out of Specification Results
EMEA - Water Quality Guideline
Health Canada - Guideline for Cleaning Validation
ICH - Q2A Text on Validation of Analytical Procedures
ICH - Q2B Validation of Analytical Procedures Methodology
ICH - Q7 GMP Guide for APIs
ICH - Q10 Pharm Quality Systems
USP - 643 TOC
USP - 643 Oct 2007 FDA Letter to USP
USP - 645 Conductivity
USP - 1010 Analytical Data - Interpretation and Treatment
USP - 1058 Analytical Instruments Qualification (draft)
USP - 1231 Water for Pharmaceutical Purposes
USP - 1225 Validation of Compendial Procedures
USP - 1226 Verification of Compendial Procedures