21 CFR 211.42 – Buildings and Facilities

A review of FDA citations for 21 CFR 211.42 Subpart C Buildings and Facilities over the past 5 years (2018-2014) from the FDA Turbo data was conducted by Performance Validation. Our analysis identified that the highest frequency of citations within the buildings and facilities subpart were consistently attributed to two code sections:

  • 21 CFR 211.42(c)(iv) A system for monitoring environmental conditions;
  • 21 CFR 211.42(c)(v) A system for cleaning and disinfecting the room and equipment to produce aseptic conditions;

The citations to these two sections are illustated below for the past 5-years.

These two citations have historically accounted for ~50-60% of all the citations generated to the buildings and facilities subpart. The most common descriptions from the FDA for these two items are:

  • Aseptic processing areas are deficient regarding the system for monitoring environmental conditions. Specifically, ***
  • Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the [room] [equipment] to produce aseptic conditions. Specifically, ***

Do you have a system to address Enviornmental Conditions in your aseptic processing areas? Do you have a method that addresses cleaning and disinfecting the room/ equipment to produce aseptic conditions? If not and you have questions please use our Contact Us page and one of PV’s experts will be in touch.

Previous 503B Data Integrity Concerns
Next 21 CFR 211.192 Production Record Review