Good storage and shipping practices for areas used to hold or store drugs, biotechnology, and medical devices require an Environmental Management System that controls temperature, humidity, and other variables that might affect the purity, quality and safety of products.

Additionally, records and documentation must be maintained to prove that parameters were kept within specifications of the products being held or shipped. Excursions of temperature, humidity or any other controlled parameters must be recorded and responded to according to the corrective and preventive action plans of the facility’s quality management system.