Current Good Manufacturing Practice (CGMP) cleanrooms are FDA mandated for pharmaceutical and medical device manufacturing.

From the FDA website:

“The CGMP regulations for drugs contain minimum requirements for the methods, facilities, and controls used in manufacturing, processing, and packing of a drug product. The regulations make sure that a product is safe for use, and that it has the ingredients and strength it claims to have.

The approval process for new and generic drug marketing applications includes a review of the manufacturer's compliance with the CGMPs. FDA assessors and investigators determine whether the firm has the necessary facilities, equipment, and ability to manufacture the drug it intends to market.”

Current Good Manufacturing Practice (CGMP) regulations

Medical Devices; Current Good Manufacturing Practice (CGMP) Final Rule; Quality System Regulation

For cleanrooms, the GMP requirements for manufacturing facilities include cleanroom classification, controlled environment (temperature and sometimes humidity), viable and non-viable particle counts, sterility, and others.

Typical GMP Cleanrooms:

• FRP cleanroom walls for chemical resistance (for cleaning with strong chemicals)
• Heat welded cleanroom vinyl floors with integral cove
• ISO-8 or better cleanroom classification
• Gown rooms
• Classified material pass thru rooms
• Comfort cooling (in more demanding cases temperature and humidity control)
• Air pressure monitoring (cleanroom Magnehelic gauges)
• Chart recorders were often used to record temperature and humidity.
• Regularly scheduled replacement of cleanroom filtration
• RSR Room Side Replaceable HEPA fan filter units.

With the move to FDA mandates, CGMP companies looked for improvements to GMP cleanrooms to justify the CGMP label. Some additions were:

• Door interlocks
• Coved cleanroom corners
• Coved cleanroom ceiling wall junction
• Digital monitoring systems for temperature, humidity and air pressure with alarm and data archiving
• Static dissipative heat welded vinyl flooring
• Continuous particle monitoring systems (non-viable)