Pakistan's Drug Regulatory Authority of Pakistan released Draft Guidelines for "Good Cold Chain Management Practices for Temperature-Sensitive Drug Products" for comments.
Time and Temperature Sensitive Drug Products (TTSDPs) require constant temperature control so that the cold chain remains integral for ensuring quality.
As a result of changing product environments, Good Storage and Distribution Practices, current regulatory trends, quality management, risk assessment factors, and temperature monitoring systems, pharmaceutical cold chain management is becoming increasingly important.
The purpose of these guidelines is to describe the principal requirements for the safe storage and distribution of time-sensitive and temperature-sensitive pharmaceutical products (TTSDPs).
To achieve this objective, it is essential to oversee the adherence of the product to appropriate quality standards throughout its shelf life and ensure that the conditions do not pose a risk of exposure to temperatures beyond their recommended storage conditions
As part of the registration process for TTSDPs, manufacturers, importers and exporters, as well as authorized distributors, are required to provide suitable storage conditions for the product throughout its life cycle. Also, Pharmacies, medical stores, and other authorized sales outlets are also required to provide appropriate storage and distribution when dispensing TTSDPs under the relevant provincial drug sale regulations.
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