Good Cold Chain Management for Temperature-Sensitive Pharmaceutical Products (Annex 1)- Edition 1

In order to maintain product quality, safety and efficacy during distribution, Good Distribution and Storage Practices specify that temperature-sensitive products are to be stored, handled and distributedcarefully throughout the distribution network.

Environmental controls play a key role in maintaining drug safety, quality and efficacy. Temperature is one ofthe most important parameters to control. Drugs must be stored, and transported according to predeterminedconditions as supported by stability data. Temperature excursions outside oftheir respective labeled storage conditions, for brief periods, may be acceptable provided stability data andscientific/technical justification exists demonstrating that product quality is not affected.

This annex is issued, to complete the Lebanese Good Storage and Distribution Practices of pharmaceutical products, by the Lebanese Ministry of Health, which stresses the importance of adhering to it by all parties involved in any aspect of the cold chain, as relevant to the particular role that they play, from the premises of the manufacturer of the product to the person dispensing or providing pharmaceutical products directly to a patient or his agent.