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COMPLIANCE & GUIDELINES
Product development standards, compliance, guidelines, regulatory requirements and certifications
Stability Guidelines
Regulatory Bodies:
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FDA: Food and Drug Administration
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EMA: European Medicines Agency
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FEA: European Aerosol Federation
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ICH: International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
STABILITY GUIDELINES
ICH Q1A(R2) : Stability testing of new drug substances and drug products
ICH Q1B : Photostability testing of new drug actives and products
ICH Q1C : Stability testing of new dosage forms
ICH Q1E : Evaluation of stability data
Stability testing of existing active substances and related finished products
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