USP: Revision of 1231 Water for Pharmaceutical Purposes
The updated 1231 Water for Pharmaceutical Purposes addresses stakeholder input by clarifying and expanding guidance on water system design, control, and testing.
Highlights:
- Ozone Removal: Ozone must be reduced to below detection levels before use in pharmaceutical processes.
- Risk-Based Additives Management: Emphasizes risk assessments for detecting and controlling added substances such as sanitizers or byproducts.
- Sampling Guidance: Supports online monitoring for TOC and conductivity, ensuring grab samples remain representative.
- Conductivity Testing Flexibility: Permits direct initiation of Stage 2 testing when using offline testing.
- TOC Clarification: The term „nominal container volume“ is defined. It refers to the intended volume that the container is designed to hold.
Organic extractable components from the packaging that contribute to the TOC profile of the sterile packaged water should have been identified, quantified, and evaluated for toxicity and safety during packaging development. - Nitrosamines: Introduces a new section highlighting the minimization of nitrosamin impurities in the water and recommends a risk-based control strategy.
The revised Chapter 〈1231〉 draft is available for free on the USP Pharmacopoeial Forum website. Registration is required but free of charge. The comment period ends on September 30, 2025.
Source:
USP: 〈1231〉 WATER FOR PHARMACEUTICAL PURPOSES – Draft
GMP Insiders: USP–NF PF 51(4) Draft Published
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