Regulatory guidelines on Pharmaceuticals Storage and distribution, Temperature controlled storage, Temperature mapping, Temperature cycling studies, Transporter qualification and validation, Good storage and shipping practices – WHO, PDA, TGA, Health Canada, ANVISA, USP guidance’s and requirements
- WHO TRS 1025 – Annex 7: Good Storage and Distribution Practices for Medical Products (June 2020)
- WHO TRS 961 – Annex 9: Model Guidance for the Storage And Transport of Time and Temperature Sensitive Pharmaceutical Products (August 2011)
- WHO TRS 961 – Annex 9, Supplement 7: Qualification of Temperature-Controlled Storage Areas (October 2011)
- WHO TRS 961 – Annex 9, Supplement 14: Transport Route Profiling Qualification (October 2011)
- WHO TRS 961 – Annex 9, Supplement 15: Temperature and Humidity Monitoring Systems for Transport Operations (October 2011)
- WHO TRS 961 – Annex 9, Supplement 13: Qualification of Shipping Containers (October 2011)
- WHO TRS 961 – Annex 9, Supplement 11: Qualification of Refrigerated Road Vehicles (October 2011)
- WHO TRS 961 – Annex 9, Supplement 8: Temperature Mapping of Storage Areas (October 2011)
- TGA: Stability testing for prescription medicines (Addresses Temperature cycling studies) – Guidance
- Health Canada; Guidelines for environmental control of drugs during storage and transportation (GUI-0069)
- 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
- ANVISA: Impact from the Recent Issuance of ANVISA Resolution RDC-53/2015 on Pharmaceutical Small Molecule Forced Degradation Study Requirements. American Pharmaceutical Review
- Industry Perspective on Temperature Cycling Studies to Meet Regulatory Temperature Excursion Support Requirements: Survey Outcome and Recommendations; Claudia Arana et al., J Pharm Sci. 2023 Dec;112(12):2981-2990
- 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)
- USP<1079>: Good Storage and Shipping Practices (Refer USP)
- USP <1118>: Monitoring Devices-Time, Temperature, and Humidity (Refer USP)
