Qvents
Discussion forum for Pharma Quality events, Regulatory Actions
Warning letters, 483s, Recalls, Import Alerts, Audit observations
Home
About Us
Contact Us
Expert Panel
Tags
Qvents
Warning Letters
483s
Recalls
Import Alerts
Quality Insights
Tags
Forums
Learning Resources
Upcoming Trainings
Training Archives
Guidelines
Pharma Jobs
Job Openings
Post a Job
Jobs posted by me
Users & Profiles
News
Login/Register
Individual
Company
Home
About Us
Contact Us
Expert Panel
Tags
Qvents
Warning Letters
483s
Recalls
Import Alerts
Quality Insights
Tags
Forums
Learning Resources
Upcoming Trainings
Training Archives
Guidelines
Pharma Jobs
Job Openings
Post a Job
Jobs posted by me
Users & Profiles
News
Login/Register
Water system
Qvents
1 minute read
Guidelines
Home
Guidelines
Water system
Updated on January 14, 2025
Home
Guidelines
Water system
Updated on January 14, 2025
USFDA
: High Purity Water System;
Guide To Inspections Of High Purity Water Systems
USFDA
Inspection Guide:
Water for Pharmaceutical Use | FDA
USFDA
: Inspection Guide:
Microbiological Pharmaceutical Quality Control Labs (7/93) | FDA
USP: FAQs
:
Water for Pharmaceutical and Analytical Purposes
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
Tags :
Guidelines
,
Purified Water
,
Water for Injections
,
Water system
Share:
Facebook
LinkedIn
Twitter
Search Posts
Latest Posts
USFDA 483 Cites Piramal Pharma for Investigation Deficiencies, Procedural Non-Compliance
March 13, 2025
Contamination Control and Data Integrity Issues: Granules India Receives USFDA Warning Letter
March 7, 2025
Janssen’s Korea Vaccine Unit USFDA 483 Cites Aseptic Operations Not in Control
February 26, 2025
Facility Registration Violations, Refusal of Inspection: Jagsonpal Issued Warning letter
February 22, 2025
Purified Water System Qualification and Control: USFDA Expectations
February 11, 2025