Good Storage and Shipping Practices for Warehouses
According to USP 1079 Good Storage and Shipping Practices, 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.
For mapping our 350,000 square foot warehouse, the system reduced the set-up time by 80%.
- Stephanie Cowan, Pharmaplan Valicor
United States Pharmacopeia Temperature Monitoring
The United States Pharmacopeia’s (USP) temperature monitoring section dictates that “a suitable number of temperature recording devices should be utilized to record temperatures and to provide temperature area maps. Thereafter, the units should be monitored in one or more locations, as determined by the results of the mapping study.”
Temperatures must be tracked and recorded and an alarm system must be in place for storage areas to ensure that any malfunction of the temperature control system does not result in product being affected by out-of-specification conditions. The General Notices also recommend annual validation/mapping of storage areas in order to maintain an accurate profile of conditions.
In parallel to the guidelines in the USP, 21 CFR Part 211, Current Good Manufacturing practice for Finished Pharmaceuticals, Section 211.142 describes written procedures for drug products. Procedures must include:
(b) Storage of drug products under appropriate conditions of temperature, humidity, and light so that the identity, strength, quality, and purity of the drug products are not affected.
Validation and Mapping
In addition, manufacturers and distributors need to perform validation/mapping studies of areas used to store and process warehouse products. Creating an accurate profile of storage conditions through a consistent validation program will establish that the environment is safe for the products it will hold and demonstrate compliance with GxP regulations. A comprehensive environmental validation program increases confidence product quality and ensures compliance during inspections.
Sensors in the Vaisala continuous monitoring system can be combined with Vaisala validation software to perform accurate environmental profiles. Truly wireless loggers, rather that thermocouple systems traditionally used in mapping applications, make the process simple and efficient. Study results are generated in secure, tamper-proof documents that aid in compliance with 21 CFR Part 11.