Abstract
Off-site storage of GMP biological and pharmaceutical products and medical devices is a critical resource for biopharmaceutical companies, contract manufacturing organizations (“CMOs”), and contract development and manufacturing organizations (“CDMOs”) facing storage and overflow issues. There are many critical factors to consider when selecting an off-site GMP storage provider.
Among the most crucial factors to consider:
1. Physical site security and accessibility
2. Facility and equipment integrity
3. Precise temperature monitoring and climate control
4. Product safety and inventory control
5. Compliance procedures