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Storage and Distribution, Transport and Validation
Qvents Team
2 minutes read
Guidelines
Home
Guidelines
Storage and Distribution, Transport and Validation
Updated on September 20, 2024
Home
Guidelines
Storage and Distribution, Transport and Validation
Updated on September 20, 2024
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)
Tags :
Stability
,
Storage
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