BRIEFING

 〈1231〉 Water for Pharmaceutical Purposes. This proposal is based on the version of the chapter official as of December 1, 2021. On the basis of comments and frequently asked questions received from stakeholders, it is proposed to make the following changes:

1. In 2. Source Water Considerations, correct a cross-reference to the subsection 3.3 Drinking Water.

2. In 3. Waters Used for Pharmaceutical Manufacturing and Testing Purposes, add a clarification about the reduction of ozone levels used for sanitization below a limit of detection prior to use of the pharmaceutical water.

3. In 5.1.3 Additives, state the need for risk assessment to ensure the use, reduction, and detection of “added substances”, if deemed appropriate.

4. In 6. Sampling, clarify the advantages of and encourage the online measurement of Total Organic Carbon 〈643〉 and Water Conductivity 〈645〉. Emphasize that, otherwise, the tested water must be representative of the water used in production. In 6.1.1 Process Control Sampling, make a minor edit to include metric units.

5. In 7.1 Chemical Tests for Bulk Waters, introduce clarifications about the flexibility of starting the conductivity test at Stage 2 without first performing Stage 1 if off-line testing is preferred. In the same section, explain the difference between the commonly known “target limit response” and the true limit for total organic carbon and emphasize the need to use USP Reference Standards.

6. In 7.2.1 Conductivity for Sterile Waters, introduce a cross-reference to 7.2.2 Total Organic Carbon for Sterile Waters to explain “nominal container volume”.

7. In 7.2.2 Total Organic Carbon for Sterile Waters, describe the “nominal container volume” as the volume that the container is intended to hold, per 〈643〉, as opposed to the volume with which it is actually filled. In the same section, explain how to identify, quantify, and evaluate the safety of any organic component contributing 0.20 mg/L of carbon or higher when performing the test for 〈643〉, Procedures, 2. Sterile Water when the result for a sterile packaged water test is between limit response 1 and limit response 2.

8. Add a new subsection, 7.5 Nitrosamines, to explain the low risk of having contributors (nitrosamines or their precursors) as well as the need for a control strategy and a risk-based approach, if deemed appropriate.

 Additionally, minor editorial changes have been made to update the chapter to current USP style.

 (GCCA: A. Hernandez-Cardoso)

 Case ID—SUB-1699