Storage qualification for pharmaceuticals and medical devices

Qualified storage according to ISO 13485

ISO 13485 requires medical device manufacturers to establish a documented procedure as well as measurement and monitoring measures to ensure the integrity of the medical devices during storage.

The warehouse must be qualified before official use to meet the described requirements for the storage of medicinal products and medical devices.

Successful warehouse qualification with Valicare: steps and measures

Valicare supports you in warehouse qualification according to regulations with the following services:
 

• Preparation of risk analyses for the warehouse and the warehouse process
• Preparation of plans for installation, operational, and performance qualification
• Creation of room books and standard operating procedures (SOPs) for cleaning, maintenance, access control, and pest control
• Validation of storage software

• Qualification of equipment such as scales and air conditioning systems
• Verification of temperature and humidity alarms as part of the functional qualification process
• Planning and execution of temperature mapping 
• Determination of hot and cold spots

• Consulting, support, and execution of the stress test for cold storage and deep-freeze rooms as well as temperature mapping in loaded condition
• Preparation of storage qualification reports
• GMP/GDP training