Stability & Hold time studies

• ICH Q1A (R2): Stability Testing: Stability testing of new drug substances and drug products
• ICH Q1B: Stability Testing: Photostability testing of new active substances and medicinal products
• ICH Q1C Stability testing: Requirements for new dosage forms (Annex to the ICH Harmonised Tripartite Guideline on Stability Testing for New Drugs and Products)
• ICH Q1D: Bracketing and matrixing designs for stability testing of drug substances and drug products
• ICH Q1E: Evaluation of stability data; ICH Q1E presentation (Sumie Yoshioka)
• ICH Q1F Stability Guideline WHO 2018: Annexure 10: Stability testing of active pharmaceutical ingredients and finished pharmaceutical products (ICH withdrew original Q1F, to follow WHO Annexure 10).
• ICH Q1: Stability Testing of Drug Substances and Drug Products (Consolidated Draft Guidance: April 2025); ICH Q1 Presentation
• EMA: Stability testing for applications for variations to marketing authorisation – Scientific guideline
• EMA: Start of shelf-life of the finished dosage form (Annex to the note for guidance on the manufacture of the finished dosage form) – Note for guidance on start of shelf-life of the finished dosage form (annex to note for guidance on the manufacture of the finished dosage form)
• EMA: Maximum shelf-life for sterile products for human use after first opening or following reconstitution – Note for guidance on maximum shelf-life for sterile products for human use after first opening or following reconstitution
• EMA: Declaration of storage conditions for medicinal products particulars and active substances (Annex) – Scientific guideline
• EMA: In-use stability testing of human medicinal products – Note for guidance on in-use stability testing of human medicinal products
• EMA: Stability testing of existing active ingredients and related finished products – Scientific guideline
• WHO TRS 953 – Annex 2, Appendix 1: Stability Testing of Active Pharmaceutical Ingredients and Finished Pharmaceutical Products: Stability Conditions for WHO Member states by region
• WHO TRS 1010 – Annex 10: WHO Guidelines on Stability Testing of Active Pharmaceutical Ingredients and Finished Pharmaceutical Products
• USFDA: Container and Closure System Integrity Testing in Lieu of Sterility Testing as a Component of the Stability Protocol for Sterile Products – Guidance for Industry
• USFDA: ANDAs: Stability Testing of Drug Substances and Products, Questions and Answers – Guidance
• USFDA: ANDAs: Stability Testing of Drug Substances and Products – Guidance
• USFDA: CVM GFI #242 In-Use Stability Studies and Associated Labeling Statements for Multiple-Dose Injectable Animal Drug Products – Guidance
• USFDA: CVM GFI #5 Drug Stability Guidelines – Guidance
• TGA: Stability testing for prescription medicines (Addresses Temperature cycling studies) – Guidance
• ANVISA: Impact from the Recent Issuance of ANVISA Resolution RDC-53/2015 on Pharmaceutical Small Molecule Forced Degradation Study Requirements. American Pharmaceutical Review
• PDA: PDA Technical Report No. 39 Revised 2021 (TR 39) Guidance for Temperature-Controlled Medicinal Products – Maintaining the Quality of Temperature-Sensitive Medicinal Products through the Transportation Environment
• Stability Studies Needed to Define the Handling and Transport Conditions of Sensitive Pharmaceutical or Biotechnological Products; Claude Ammann, AAPS PharmSciTech, Vol. 12, No. 4, December 2011 (# 2011)

Hold time studies:

• WHO TRS 992 – Annex 4: General guidance on hold-time studies
• EMA: Section 4.4. ‘Controls of Critical Steps and Intermediates’ – ‘Storage of intermediate and bulk products’ – Guideline on manufacture of the finished dosage form’
• EMA: Stability – Stability issues of pharmaceutical bulk products use in manufacture of the finished product; European Medicines Agency (EMA) Quality of Medicines Questions and Answers: Part 2