Proper storage conditions for active pharmaceutical ingredients (APIs) is important to ensure the identity, strength, quality, and purity of the products are not affected. According to the FDA Guidance Document Q7 Good Manufacturing Practices for Active Pharmaceutical Ingredients, Section X Storage and Distribution:
“Facilities should be available for the storage of all materials under appropriate conditions (e.g., controlled temperature and humidity when necessary). Records should be maintained of these conditions if they are critical for the maintenance of material characteristics.”
A company recently received the following observation:
….. Proper storage conditions for API products are not followed or documented.
a. Your firm does not document how API products are stored at your warehouse. For example, during the inspection it was observed that … API samples for lots … and … were being kept at refrigerated temperatures.
b. Nine out of … months your firm’s building system temperature monitoring, …, had temperature excursions falling outside of the temperature requirement of … degree Fahrenheit. Data for the warehouse temperature monitoring during the summer was unable to be provided by your firm. Your firm’s written procedure SOP …. “Standard Operation Procedure of Humidity and Temperature Monitoring in Warehouse” states “if temperatures are noted to be out with the recommended range then this must be recorded along with any action taken to resolve the issue.” Your firm did not justify nor investigate on any of the temperature excursions.
For more additional information regarding APIs, refer to FDA Guidance Document, Q7 Good Manufacturing Practices for Active Pharmaceutical Ingredients – Questions and Answers.
To view more observations pertaining to APIs, refer to the following GMP Trends® Issues: 1097, 1092, 1087, and 1082.
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