Pharmacopeial References
- United States Pharmacopeia, General Informational Chapter <71>. Sterility Tests. Rockville. MD.
- United States Pharmacopeia, General Informational Chapter <85>. Bacterial Endotoxins Test. Rockville. MD.
- United States Pharmacopeia, General Informational Chapter <788>. Particulate Matter in Injections. Rockville, MD.
- United States Pharmacopeia, General Informational Chapter <1046>. Cell and Gene Therapy, Rockville. MD.
- United States Pharmacopeia, General Informational Chapter <1043>. Ancillary Materials Used in the Manufacturing of Cell Therapy Products. Rockville. MD.
- United States Pharmacopeia, General Informational Chapter <1223. Validation of Alternative Microbiological Methods. Rockville. MD.
- European Pharmacopeia 2.6.1. Sterility.
- European Pharmacopeia 2.6.27. Microbiological Control of Cellular Products.
- European Pharmacopeia 5.1.6. Alternative Methods for Control of Microbiological Quality.