USP revises Chapter <1231> on Pharmaceutical Water
Recommendation
28/29 January 2025
Generation, Monitoring & Compliance
Register now for ECA's GMP Newsletter
Changes to the fundamental monograph on pharmaceutical water <1231> Water for Pharmaceutical Purposes from the US-American Pharmacopeia have been published for comments in the Pharmacopeial Forum 41(5). The revision presented in the current draft mainly has a structural nature. The content of the monograph has been reorganised in 9 new chapters which aim at improving readibility and searchability of the content searched:
1. INTRODUCTION
2. SOURCE WATER CONSIDERATIONS
3. WATERS USED FOR PHARMACEUTICAL MANUFACTURING AND TESTING PURPOSES
4. VALIDATION AND QUALIFICATION OF WATER PURIFICATION, STORAGE, AND DISTRIBUTION SYSTEMS
5. DESIGN AND OPERATION OF PURIFIED WATER AND WATER FOR INJECTION SYSTEMS
6. SAMPLING
7. CHEMICAL EVALUATIONS
8. MICROBIAL EVALUATIONS
9. ALERT AND ACTION LEVELS AND SPECIFICATIONS
The draft document is available for free on the website of the USP Pharmacopeial Forum. You only need to register for free. The deadline for comments is 20 November 2015.
Related GMP News
11.12.2024Warning Letter to Indian Manufacturer of Sterile Ophthalmic Drop Products
06.11.2024FDA Warning Letter to a US Manufacturer of Medical Gases
30.10.2024WHO Guidance on Wastewater and Solid Waste Treatment in the Antibiotics Production
23.10.2024Warning Letter to Indian sterile Manufacturer due to Cross-Contamination and Particles
16.10.2024Do Parenterals have to be 100% free of Particles?
02.10.2024Does Purified Water have to be tested for Endotoxins?