White Paper — Sponsored Content

GMP Warehouse Mapping: A Step-by-step Guide for validating storage facilities

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GMP Warehouse Mapping: Step-By-Step Guidelines for Validating Life Science Storage Facilities

Good manufacturing practice (GMP) requires mapping studies to profile and document conditions in warehouses, distribution centers, and storage facilities. This white paper describes best practices for mapping studies that aid in compliance with global regulations and guidance. We recommend a nine-step process for mapping/validation and address particulars such as risk assessment, sensor placement, humidity mapping, study intervals and duration. Links to current regulatory and guidance documents included. Although the paper is written for warehouses, the principles can be applied to mapping any area.

Steps to Compliant Warehouse Mapping:

  • Create a Validation Plan
  • Identify areas at risk
  • Develop Protocol Information
  • Determine sensor distribution
  • Select suitable technology
  • Set up mapping equipment
  • Conduct test and review data
  • Make modifications
  • Document and schedule mapping study

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