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GMP vs cGMP in Cleanrooms: What’s the Difference?

noviembre 28, 2022
FDA Logo, CGMP Logo
Figure 1. FDA logo CGMP

GMP stands for Good Manufacturing Practice and cGMP stands for Current Good Manufacturing Practice. Both are standards by the US federal government Food and Drug Administration FDA that regulate the development, manufacturing, testing and sale of food, pharmaceuticals, and medical devices in the United States. There are similar GMP standards in Europe and the rest of world. Cleanrooms constitute the controlled environment in which most of these pharmaceutical and medical devices are manufactured and thus are subject to GMP and cGMP standards.

In the 1950’s and 1960’s poor testing and manufacturing of pharmaceutical like Sulphathiazole and Thalidomide resulted in deaths of hundreds of people as well as birth defects. These incidents led the FDA to revise manufacturing and quality control requirements leading to what eventually became known as GMPs. Congress required companies not only to ensure products were safe, but also effective and manufacturers were required to report adverse events. In the 1970’s GMPs for drugs were significantly expanded and GMPs were made final for medical devices.

GMP regulations address all aspects of pharmaceutical and medical device manufacturing, packaging, and labeling including cleanliness and sanitation, equipment function and use, recordkeeping, personnel, operations and processes, product testing, and addressing errors and complaints. Pharmaceutical and medical device manufacturers must document clearly procedures and processes. They also must have quality assessment and control measures in place. Manufacturers must also perform essential testing and validation (i.e., does the process or equipment do what it is supposed to do) of equipment and operations. All processes must be reliable (i.e., produce the same result every time) with minimal variation. All equipment, techniques, and processes must be up to date. This includes R&D, manufacturing, and testing facilities like cleanrooms.

The FDA website is an excellent source of information on GMP and CGMP.

Click here to learn more information on GMP and CGMP.

Golden rules of GMP as they apply to cleanrooms design and operation:

  • Get the cleanroom facility design right from the start
  • Validate cleanroom processes
  • Write good cleanroom procedures and follow them
  • Identify who does what in cleanroom
  • Keep good cleanroom records
  • Train and develop cleanroom staff
  • Practice good cleanroom hygiene
  • Maintain cleanroom facilities and equipment
  • Build quality into the whole product lifecycle
  • Perform regular cleanroom audits

Concerned that the GMP practices that had been in place for decades was no longer up to par, the FDA modified the requirements to CGMP (Current Good Manufacturing Practices) to ensure that companies are using the best equipment and most up to date practices. CGMP has replaced GMP as the standard for pharmaceutical and medical device manufacturing.

Older features in cleanrooms that are still important GMP:

  • Cleanable and chemical resistant cleanroom walls
  • Heat welded vinyl cleanroom floor with integral cove
  • Cleanroom Air locks
  • Interlocked cleanroom gown room doors
  • Cleanroom Temperature and RH control
  • Magnehelic gauges
  • Pass thru’s
  • Air showers
  • Annual cleanroom particle test
  • Cleanroom disinfecting UV light systems
  • Cleanroom De-ionizing systems
  • Cleanroom Reverse osmosis DI water systems

Examples of some new features in cleanrooms that could be considered upgrades to make something CGMP:

  • Continuous particle counting systems in cleanrooms
  • Cleanroom Digital temperature alarms
  • Cleanroom Digital room pressure alarms
  • Cleanroom Digital storage of temperature and room pressure data
  • Cleanroom Hands free bootie systems
Property American Cleanroom Systems 2022

The author Anthony Chien has worked at American Cleanroom Systems for the past 10 years. He has more than 40 years of cleanroom experience. Anthony has a BS and MS in Electrical Engineering specializing in semiconductor manufacturing from the University of Illinois. American Cleanroom Systems is a design-build modular cleanroom manufacturer based in Rancho Santa Margarita CA. American Cleanroom Systems is your expert in ISO-5 thru ISO-8 (class 100 to class 100k) modular cleanrooms for pharmaceutical cleanrooms, medical device cleanrooms, and industrial cleanrooms.
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