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लाइफ साइंसेज़ eQMS 19 आइटम

GDP Cold-Chain Distribution Checklist

यह चेकलिस्ट अंग्रेज़ी में है।

Confirms good distribution practice controls for temperature-sensitive medicinal products across storage, shipping, and receipt. Use to audit distribution operations and qualify cold-chain shipping lanes.

EU GDP Guidelines 2013/C 343/01WHO TRS 961 Annex 9USP <1079>

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Quality System and Responsibilities

  • Is a quality system in place with a designated Responsible Person for distribution? *
  • Are SOPs approved for storage, transport, receipt, and returns of temperature-sensitive products? *
  • Are personnel trained on GDP and cold-chain handling? *
  • Are suppliers and customers qualified and verified as authorized? *

Storage and Temperature Mapping

  • Are storage areas temperature-mapped to identify hot/cold spots before use? *
  • Are refrigerators, freezers, and cold rooms continuously monitored with alarms? *
  • Is monitoring equipment calibrated and traceable? *
  • Record the required storage temperature range for the product.

Shipping Qualification and Packaging

  • Are shipping containers/systems qualified for the required temperature profile and duration? *
  • Are packout procedures validated for summer and winter (worst-case) conditions? *
  • Are temperature data loggers included in shipments as required? *
  • Are transport lanes/routes qualified for transit time and ambient exposure? *

In-Transit Monitoring and Receipt

  • Is temperature data reviewed on receipt before product is placed into saleable stock? *
  • Are received goods quarantined until temperature and integrity are verified? *
  • Is the cold chain maintained during loading, transit, and unloading? *

Excursion and Deviation Management

  • Is a temperature excursion procedure in place with defined product-impact assessment? *
  • Are excursions assessed against product stability data before disposition? *
  • Are falsified/suspected product and returns handled per procedure? *
  • Are excursions trended and CAPAs implemented? *

पूरी GDP Cold-Chain Distribution Checklist चेकलिस्ट डाउनलोड करें

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