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GMP/GDP-compliant
GMP/GDP-compliant Warehouse Qualification

Storage qualification for pharmaceuticals and medical devices

Valicare qualifies your warehouse according to regulatory GMP and/or GDP requirements, prepares the compliant documentation, and trains your staff.

The storage of pharmaceutical products must meet the requirements of the valid standards and laws such as AMG and 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."

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
Free first consultation now!

Free first consultation now!

 

Dr. Ellen Sons-Brinkmann
Phone: +49 69 153 293 709

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Our Company

Valicare is an ISO 9001-certified service company and operates in the area of qualification and validation of technical equipment and processes.