ICH GUIDELINE FOR STABILITY TESTING


·         Describes regarding sampling times, storage conditions& specific test parameters for each dosage form.
·         The FDA & The expert working group of the ICH of technical requirements for the registration of pharmaceuticals for human use have published guidelines for conducting the actual studies.
·         ICH guideline as follow,
o   Quality Guidelines “Q” (chemical and pharmaceutical QA)
o   Safety Guidelines “S” (in vitro and in vivo pre-clinical studies)
§  covering Carcinogenicity Testing, Genotoxicity Testing,
§  Toxicokinetics and Pharmacokinetics ….. etc.
o   Efficacy Guidelines “E” (clinical studies in human subject)
§  Covering clinical safety, Dose Response Studies, Good 
§  Clinical Practices, Clinical evaluation …. etc.
o   Multidisciplinary Guidelines “M”
§  Covering Medical Terminology, Electronic Standards for
§  Transmission of Regulatory Information …… etc.
§  Important for Stability
§  Guideline M4: The Common Technical Document (CTD)
ICH Guideline “Q”:
·         Stability Testing (Q1)
o   Stability Testing in Climatic Zone I and II (Q1A)
§  Stability testing protocol including temperature, humidity and trial duration.
o   Photo stability Testing (Q1B)
§  Protocol required to evaluate light sensitivity and stability of New substances.
o   Stability Testing for New Dosage Forms (Q1C)
§  Main stability guideline for new formulation & stability data required.
o   Bracketingand Matrixing Designs (Q1D)
§  General principle to reduce stability testing & provide example.
o   Evaluation of Stability Data (Q1E)
§  Statistical approach to stability data analysis
o   Stability Testing in Climatic Zones III and IV (Q1F)
§  Acceptable storage condition
·         Validation of Analytical Procedures (Q2)
·         Impurities (Q3)
·         Pharmacopoeial Harmonization (Q4)
·         Biotechnological Products (Q5)
Specifications (Q6)

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