Environmental Monitoring and Validation in cGMP-compliant Warehouses and Storage Areas - Vaisala

The Vaisala continuous monitoring system for warehouses and distribution centers ensures gap-free records for compliance with Good Manufacturing Practice in the United States, Canada, the European Union, Japan, Australia, and China.  With increasing globalization of pharmaceuticals and biotechnology, these products now ship to more widely distributed locations than ever before. Parallel to this trend is an increased regulatory focus on storage and distribution for drugs, biologicals and medical devices.

The Vaisala continuous monitoring system reduces the risk of non-compliance with regulatory requirements for monitoring temperature, relative humidity, and other critical parameters in temperature controlled and refrigerated warehouses. The 24/7 alarming reduces the risk of lost product due out-of-tolerance conditions and reporting is designed for compliance with 21 CFR Part 11. The system comprises viewLinc software with Vaisala’s high-accuracy data loggers and sensors. With easy connectivity to your existing network, the monitoring system easily scales up to 1000+ monitored locations.

Vaisala loggers have on-board memory and power, making them immune to power outages and easy to place where electrical outlets are not feasible. For high- traffic warehouse environments and hard-to-reach shelving, we offer a wireless sensor that is easy to place. This also ensures that sensing devices can be placed so that they are not subjected to environmental extremes that might affect their performance (USP 1079).

What our customers say

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 parameter must be recorded and responded to according to the Corrective & Preventive action plans of the facility’s quality management system.

 
The USP’s Temperature Monitoring section under “Environmental Management System” 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.