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Water system
Qvents
1 minute read
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Home
Guidelines
Water system
Updated on March 12, 2025
Home
Guidelines
Water system
Updated on March 12, 2025
USFDA
: High Purity Water System;
Guide To Inspections Of High Purity Water Systems
ISPE
:
Baseline Guide Vol 4: Water & Steam Systems 3rd Edition (To be purchased)
ISPE
:
Good Practice Guide: Commissioning & Qualification of Pharma Water & Steam Systems (Second Edition)
EMA (European Medicines Agency):
Quality of water for pharmaceutical use – Scientific guideline (EMA)
Note for Guidance on Quality of Water for Pharmaceutical Use (EMA)
Questions and answers on production of water for injections by non-distillation methods – reverse osmosis and biofilms and control strategiesÂ
(EMA)
WHO
WHO TRS 1033 – Annex 3
:
Good Manufacturing Practices: Water for Pharmaceutical Use
(
Revision of WHO TRS, No. 970, Annex 2, 2011
)
WHO TRS 1025 – Annex 3
:
Production Of Water for Injection by means other than Distillation
WHO
Guidelines for drinking-water quality, 4th ed., incorporating the 1st addendum (chapters)
Ph Eur. Monograph (European Pharmacopeia or EP) –Â
Read (Water for Injections (0169); Water for preparation of extracts (2249); Purified Water (0008);
USP 1231:
Water for Pharmaceutical Purposes (Read)
PIC/S
: Inspection of UtilitiesÂ
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