What temperature storage requirements must be followed?

• A. Proper storage temperature and relative humidity (RH) requirements
• B. No specific temperature rules
• C. Temperature only
• D. Relative humidity only

Answer: (A)

Controlling the storage environment means managing both temperature and relative humidity. Temperature governs how quickly spoilage and pathogenic microbes can grow and affects overall product stability, while relative humidity influences moisture moves, condensation, packaging integrity, texture, and mold risk. In GMP storage, procedures specify acceptable ranges for both parameters and require monitoring to ensure they stay within limits. That combination helps prevent spoilage and safety issues and keeps product quality intact.

The best choice reflects this dual control: it requires proper storage temperature and relative humidity. Failing to specify either aspect leaves risks unchecked—no specific rules omit safety, temperature only ignores humidity-related problems, and humidity only ignores temperature-related risks.