eSTAR - Electronic Stability Testing Analyses & Reporting
FDA LINKS
For more information on 21 CFR Part 11, please visit
the FDA's website here:
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FDA Website - 21
CFR Part 11 description
For your convenience, we provide a direct link
to the FDA's Center for Drug Evaluation and Research (CDER) website:
(This will open a new browser window)
FDA-CDER
Direct Link
WORLDWIDE VARIOUS DRUG AUTHORITIES
USFDA - United States Food Drug Administration, United States
TTP - Therapeutic Products Proogramme, Canada
ICH - International Conference on Harmonisation, Switzerland
TGA - Therapeutic Goods Administration, Australia
NIHS - National Institute of Health Science, Japan
EMA - EU - European Medicines Agency, European Union
CDSCO
- Central Drugs Standard Control Organization, India
HSA
- Health Sciences Authority, Singapore
SFDA
- State Food and Drug Administration, China
TFDA
- Taiwan Food and Drug Administration, Taiwan
KFDA
- Korea Food and Drug Administration, Korea
Roszdravnadzor,
Russia
QUALITY GUIDELINES FOR STABILITY
Q1A(R2) - Stability Testing of New Drug Substances and Products
Q1B - Stability Testing : Photostability Testing of New
Drug Substances and Products
Q1C - Stability Testing for New Dosage Forms
Q1D - Bracketing and Matrixing Designs for Stability
Testing of New Drug Substances
Q1E - Evaluation of Stability Data
Q1F - Stability Data Package for Registration Applications
in Climatic Zones III and IV