Are your products being stored under appropriate conditions?

Proper storage of pharmaceutical products is important to ensure the identity, strength, quality, and purity of the products are not affected.  Storage areas:

  • Must have the appropriate conditions of temperature, humidity, and light
  • Must prevent unauthorized persons from entering
  • Should be of sufficient capacity
  • Should be clean and dry
  • Should be free of accumulated waste and vermin
  • Should protect materials and products from weather
  • Should segregate quarantined, approved, and rejected materials.
porper storage of pharmaceutical products

In addition, material must be stored under the proper storage conditions as indicated on the product labeling, the storage conditions must be monitored, records must be kept of all activities, including but not limited to each delivery, retest and expiration dates, and issuing of materials.

A company recently received the following observation:

….. Drug products are not stored under appropriate conditions of temperature and humidity so that their identity, strength, quality, and purity are not affected.

Specifically, the storage conditions of the drug products within your warehouse are inadequate in that the drug products are not stored at the recommended storage conditions indicated by the manufacturer. For example, there were several days where the temperature exceeded the recommended storage conditions at the time of the recording. In addition, on the … Warehouse Temperature & Humidity Log indicated the measurements were required to be taken …. This time does not represent the worst-case condition of the warehouse.

For more information regarding good storage and distribution practices, refer to the following: Code of Federal Regulations 21 CFR 211.142(b) Warehousing Procedures, USP General Chapter <1079> Good Storage and Distribution Practices, and The World Health Organizations Technical Report Guide to Good Storage Practices for Pharmaceuticals.

To view more observations pertaining to storage, refer to the following GMP Trends® Issues: 1053, 1051, 1046, and 1040

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