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IV Pan American Conference on Drug Regulatory Harmonization Dominican Republic March 2 – 4, ... - page 2 / 15

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Chapter 5: Storage Areas

Objective

Verify that storage areas are designed or adapted with sufficient capacity and proper separation/organization, maintained, and procedures in place to ensure good storage conditions of materials and products.

Main Aspects

Storage areas of sufficient capacity for starting and packaging materials, intermediates, bulk and finished products, products in quarantine, and released, rejected, returned or recalled products

Clean, dry, sufficiently lid and maintained within acceptable temperature limits

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