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India Draft Guidance Aims at Better Control of Biologics During Transport, Storage


Distributors of biological products must maintain records of temperature monitoring data and check temperatures during transport and storage at defined intervals, according to a draft guidance by India’s Central Drugs Standard Control Organization (CDSCO).

Monitoring equipment should also be regularly checked and all temperature-related records maintained for the shelf-life of the product plus one year, the Sept. 17 draft states.

Moreover, storage facilities should be temperature-mapped to ensure uniformity across the area, with particular attention given to areas that are susceptible to fluctuations. An alarm system “shall be in place to provide alerts when there are deviations from predefined storage conditions,” according to the draft.

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