21 CFR Part 211 - Current Good Manufacturing Practice
Buildings and Facilities

21 CFR Part 211 - Current Good Manufacturing Practice 211.42: Design and Construction of Buildings

Buildings used for manufacturing must be of suitable size, construction, and location to facilitate cleaning, maintenance, and proper operations including prevention of mix-ups and contamination.

Maintained by Gerard BlokdykVerified against the published standard Control text last updated

What else in your programme already covers this

This control maps to 4 controls across 1 other frameworks. If you already hold one of them, the evidence you collected for it is the starting point here rather than new work.

  • 58.41 General Facility Requirements
  • 58.43 Animal Care Facilities
  • 58.47 Laboratory Operation Areas
  • 58.51 Specimen and Data Storage Facilities

Every mapping shown was judged rather than inferred from wording similarity, and the ones that failed review are published too. See the coverage reports and what was rejected.

Other controls in Buildings and Facilities

Query this from an agent

The graph holds this control, the 4 it maps to, and the evidence behind each claim, over MCP and REST.