21 CFR § 610.30 – Test for Mycoplasma.
Summary
This section of the U.S. Code of Federal Regulations was revoked by the FDA in August 2020. It previously prescribed specific culture-based and indicator-cell assays for mycoplasma detection in live virus vaccines. The regulation was removed to provide manufacturers with the flexibility to use more modern, scientifically sound, and validated methods that are consistent with current pharmacopeial chapters and international guidelines.
Key Principles & Scope
Previous Requirement: This regulation formerly mandated two specific, slow, culture-based methods for ensuring products were free from mycoplasma contamination.
Reason for Revocation: The FDA removed the prescriptive regulation to better align with modern, harmonized standards. This encourages the adoption of more rapid and sensitive technologies, such as Nucleic Acid Amplification Techniques (NAT), as described in USP <63>.
Current Best Practice: The requirements for mycoplasma testing are now defined by the principles within key compendial chapters and guidance documents, which are considered current Good Manufacturing Practice (cGMP).
Official Source
https://www.ecfr.gov/on/2020-09-30/title-21/chapter-I/subchapter-F/part-610/subpart-D/section-610.30
Supporting Materials
- USP <63> Mycoplasma Tests
- https://doi.usp.org/USPNF/USPNF_M3687_01_01.html
- ICH Q5A(R2) Guideline on viral safety evaluation of biotechnology products derived from cell lines of human or animal origin – Scientific guideline
- https://www.ema.europa.eu/en/ich-q5ar2-guideline-viral-safety-evaluation-biotechnology-products-derived-cell-lines-human-or-animal-origin-scientific-guideline
- https://www.fda.gov/files/vaccines,%20blood%20%26%20biologics/published/Points-to-Consider-in-the-Characterization-of-Cell-Lines-Used-to-Produce-Biologicals.pdf
These related links show posts on this site that reference this page. They do not necessarily mean that this guidance directly applies to every modality, product type, or quality attribute listed below.