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GDP/GMP-compliant storage for medical technology & pharmaceutical industry

In this white paper from May 2023 by our technical expert, we have compiled practical tips for you on the procedure for GMP-compliant qualification of storage areas. The focus is on carrying out climate distribution measurements.

Documentation of a risk-based warehouse qualification in the GMP area

Stored, compliance-relevant products from the pharmaceutical industry and medical technology must always be available in perfect quality. National and international quality assurance regulations that apply worldwide must be observed.
In our new white paper, we have compiled practical tips for you on the procedure for GMP-compliant qualification of storage areas. The focus is on carrying out temperature and humidity distribution measurements, also known as mappings, and integrating a validatable environmental monitoring system.

Contents:

  • Regulatory requirements
  • Planning and carrying out warehouse qualification
  • Risk analyses
  • Climate distribution measurements
  • Positioning the environmental monitoring system
  • Calibration/recalibration/revalidation

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