Documentation

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Documents

FDA Guidance Documents

FDA Data Integrity and Compliance

MHRA GxP Data Integrity Guide

TGA Data Management and Data Integrity

Health Canada Guidelines Documents

IPA Good Documentation Practices

Quality Control

WHO ( Good practices Pharmaceutical Quality Control Laboratories TRS957 Annex.pdf )

FDA 21 CFR Part=211 subpart I Laboratory Control

Quality Assurance

EMA Pharmaceutical Management system.pdf

TGA Pharmaceutical Quality System

FDA Pharmaceutical Quality System

ICH Q10 Guideline.pdf

Microbiology

WHO Good Practices Pharmaceutical Microbiology Laboratories TRS961

USP 35 <1117> Microbiological Best Laboratory Practices

FDA Pharmaceutical Microbiology Manual.pdf