H WHO Guidelines H WHO Guidelines
as of 2019 - 05 - 07
H.4 WHO good manufacturing practices: water for pharmaceutical use (Technical Report Series, No. 970 (2012), Annex 2)
1. Introduction
1.1 Scope of the document
1.2 Background to water requirements and uses
1.3 Applicable guides
2. General principles for pharmaceutical water systems
3. Water quality specifications
3.1 General
3.2 Drinking-water
3.3 Bulk purified water
3.4 Bulk highly purified water
3.5 Bulk water for injections
3.6 Other grades of water
4. Application of specific types of water to processes and dosage forms
5. Water purification systems
5.1 General considerations
5.2 Production of drinking-water
5.3 Production of purified water
5.4 Production of highly purified water
5.5 Production of water for injection(s)
6. Water storage and distribution systems
6.1 General
6.2 Materials that come into contact with systems for water for pharmaceutical use
6.3 System sanitization and bioburden control
6.4 Storage vessel requirements
6.4.1 General
6.4.2 Capacity
6.4.3 Contamination control considerations
6.5 Requirements for water distribution pipework
6.5.1 General
6.5.2 Temperature control and heat exchangers
6.5.3 Circulation pumps
6.5.4 Biocontamination control techniques
7. Operational considerations
7.1 Start-up and commissioning of water systems
7.2 Qualification
7.3 Continuous system monitoring
7.4 Maintenance of water systems
7.5 System reviews
8. Inspection of water systems
Further reading
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