Good distribution and storage practice for the pharma cold chain

Where the guidance comes from

• WHO: Good storage and distribution practices for medical products (TRS 1025, Annex 7, 2020), which combines earlier separate GDP and GSP guidance into one document built on a quality system and risk management.
• WHO: Model guidance for the storage and transport of time- and temperature-sensitive pharmaceutical products (TRS 961, Annex 9) and its technical supplements on mapping, qualification, monitoring, calibration and refrigeration maintenance.
• CDSCO: Guidelines on Good Distribution Practices for Biological Products, effective October 2012.
• CDSCO: draft Guidelines on Good Distribution Practices for Pharmaceutical Products, released for comment — check CDSCO's website for the current status before relying on it.

The core principles

Across these documents the logic is the same. Everyone who handles a medicine shares responsibility for its quality. Risks are identified and controlled at every step, not assumed away. Storage conditions follow the product's label. Equipment is shown to work before use, monitored during use and maintained. Records prove all of this. And deviations are investigated, not hidden.

What it means for refrigeration equipment

People and procedures

Equipment is only half of the system. GDP guidance expects written procedures for receiving, storing, monitoring, cleaning and handling failures, and staff trained to follow them. For a busy pharmacy or distributor, that can be as simple as a laminated sheet beside each fridge: who checks it, when, what the limits are, and who to call.

Assign a named person for each cabinet or store, with a deputy for nights, weekends and holidays. Most cold chain losses happen when the usual person is away.

Receiving and dispatch

• Check temperature records or indicators on every incoming cold shipment before accepting it.
• Move cold stock into storage straight away; don't let it queue behind ambient deliveries.
• Pack outgoing cold shipments with conditioned coolants and qualified boxes, not frozen packs straight from a freezer against freeze-sensitive product.
• Use first-expiry, first-out picking and record batch numbers.

India-specific risks to plan for

Indian distribution adds challenges that GDP documents anticipate in general terms: summer ambient temperatures above 40 °C, long and unpredictable power cuts, voltage swings that damage compressors, and long road journeys between hubs and towns. CDSCO's biologicals guideline itself was written with the country's wide temperature variations in mind.

In practice that means rated-ambient checks on every cabinet, voltage protection, generator or inverter backup with fuel and maintenance plans, and seasonal mapping of stores that aren't air-conditioned.

Where a small business should start

You don't need a pharmaceutical factory's quality department to apply the principles. Start with a list of cold products and their label conditions, a suitable cabinet with an independent logger, a daily check sheet, a maintenance contract, a backup plan and a simple excursion procedure. Then ask your State Drugs Control authority or your customers what additional documentation they expect.