Guest Column

How To Select The Appropriate Flooring System For Your GMP Facility

Eric Bohn

In today’s construction industry, there is an overabundance of flooring materials available for installation in your facility. The quality, cost, and functionality of these options vary wildly. You can run down to your local home improvement store and purchase vinyl tile for less than $1/square foot or spend over $20/square foot for specialty products of exceptional quality and durability. With so many choices, it is not always easy to know which flooring system is appropriate for your cGMP facility.  However, bear in mind that global GMP regulations require finishes to be smooth and easily cleanable as illustrated in the following examples:

  • FDA 21 CFR Part 211 Current Good Manufacturing Practice for Finished Pharmaceuticals, Subpart C--Buildings and Facilities – “Any building or buildings used in the manufacture, processing, packing, or holding of a drug product shall be of suitable size, construction and location to facilitate cleaning, maintenance, and proper operations.”
  • The EU Guidelines to Good Manufacturing Practice, Chapter 3 – “Where starting and primary packaging materials, intermediate or bulk products are exposed to the environment, interior surfaces (walls, floor and ceilings) should be smooth, free of cracks and open joints, and should not shed particulate matter and should permit easy and effective cleaning and , if necessary, disinfection.”
  • ICH Q7 Current Manufacturing Guide for Active Pharmaceutical Ingredients, Section V – “Buildings and facilities used in the manufacture of intermediates and APIs should be located, designed, and constructed to facilitate cleaning, maintenance, and operations as appropriate to the type and stage of manufacture.”