GMP/ GDP-Compliant Warehouse Qualification

GMP/GDP compliant storage qualification for pharmaceutical and medical device companies according to valid standards and laws

Valicare qualifies your warehouse according to the requirements, prepares the GMP-compliant documentation and trains your staff.

The storage of pharmaceutical products must meet the requirements of the valid standards and laws such as AMG, AMWHV as well as the GMP and GDP guidelines.

The EU GMP Guideline Part 1 Chapter 3.3 quotes: Lighting, temperature, humidity and ventilation should be appropriate and such that they do not adversely affect, directly or indirectly, either the medicinal products during their manufacture and storage, or the accurate functioning of equipment.

ISO 13485 requires the organization (medical device manufacturer) to establish a documented procedure and measurement and monitoring measures to ensure the integrity of the medical devices during storage.

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

Valicare supports you in warehouse qualification, considering the current regulatory, with the following services:
 

• Preparation of risk analyses for the warehouse and the warehouse process
• Preparation of plans for installation, functional 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, 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 the temperature mapping in loaded condition
• Preparation of storage qualification reports
• GMP/GDP trainings 
• GMP/GDP Certificate