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)
FAQs About CGMP Cleanrooms
Q: What is a GMP cleanroom?
A: A GMP cleanroom is designed to comply with all FDA requirements for FDA Good Manufacturing Practice (GMP). GMP requirements for cleanroom manufacturing facilities include cleanroom classification, controlled environment (temperature and sometimes humidity), viable and non-viable particle counts, sterility, and others.
Q: What is a CGMP cleanroom?
A: A GMP cleanroom is designed to comply with all FDA requirements for FDA Current Good Manufacturing Practice (CGMP). CGMP companies look for improvements to GMP cleanrooms to justify the CGMP label. Features commonly include: interlocks, coving, monitoring systems, and static dissipative heat welded vinyl flooring.
Q: What products require a CGMP cleanroom?
A: FDA CGMP typically applies to pharmaceutical products.
Q: What is EU annex GMP annex 1 for cleanrooms?
A: This is European regulations for manufacturing pharmaceutical products. It differs from USA FDA CGMP.
Q: What are requirements for equipment going into CGMP cleanrooms?
A: The equipment must not have a negative impact on product quality. The equipment must be easy to clean. The equipment must comply with the applicable technical regulations. The equipment must be suitable for its purpose.
Q: What is FDA validation and how is it part of a cGMP cleanroom?
A: FDA validation is the FDA approval process for new pharmaceutical products/drugs. Among items included is drug development, testing, manufacturing, training, equipment, facilities, QA program, and documentation.
Q: Do I need to do continuous particle testing in my cleanroom?
A: Continuous cleanroom particle counting within cGMP is only a requirement in Grade B and Grade A environments. Both are ISO-5 at rest. Grade A is high risk operations like filling, open ampoules, and aseptic preparation. Grade B is background area for grade A and has less stringent operational particle requirements.
Spanish 
