Overview of the Requirements on WFI in the EU, USA and Japan
Recommendation
17-19 September 2024
GMP Compliance and Technology for the Manufacture of Oral Solid Dosage Forms
Register now for ECA's GMP Newsletter
Again and again, the question arises about the limits laid down in the different GMP regulations and Pharmacopoeias and what procedures are applicable to the manufacture of water for injection (WFI). The table below gives you an overview of the current requirements on the production as well as on certain testing elements. It is remarkable to notice that only EU authorities are against the inclusion of membrane procedures for the production of WFI.
|
| USP | EP | JP |
| Production of WFI | Distillation or purification process proven to be equivalent or superior to distillation | Distillation only | Distillation or RO/UF |
| Conductivity [µS/cm at 25 °C or equivalent at other temperatures] | 1.3 | 1.3 | 1.3 |
| TOC [ppb] | ≤ 500 | ≤500 | ≤ 500 |
| Endotoxin | 0.25 EU/mL | 0.25 EU/mL | 0.25 EU/mL |
| Bacteria [cfu/100 mL] | 10 | 10 | 10 |
| Nitrates [ppm] | N/A | 0.2 | N/A |
| Ammonium [mg/L] | N/A | N/A | N/A |
Related GMP News
09.09.2024Humidity in pharmaceutical Cleanroom Walls after a Leakage
28.08.2024FDA Warning Letter to pharmaceutical Manufacturer in Puerto Rico
06.08.2024Is it possible to remove a Biofilm in pharmaceutical Water Systems?
06.08.2024Problems in Clean Room at Contract Manufacturer of sterile Eye Preparations
31.07.2024FDA criticizes Water System at Korean Sunscreen Manufacturer
31.07.2024Containment: What is the Difference between OEB and OEL