Water For Pharmaceuticals Proposes

USP-NF https://online.uspnf.com/uspnf/document/GUID-07416921-813B-43A...
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1. INTRODUCTION
2. SOURCE WATER CONSIDERATIONS
3. WATERS USED FOR PHARMACEUTICAL MANUFACTURING AND TESTING PURPOSES
3.1 Bulk Monographed Waters and Steam
3.1.1 Purified Water

3.1.2 Water for Injection
3.1.3 Water for Hemodialysis
3.1.4 Pure Steam
3.2 Sterile Monographed Waters
3.2.1 Sterile Purified Water

3.2.2 Sterile Water for Injection
3.2.3 Bacteriostatic Water for Injection
3.2.4 Sterile Water for Irrigation
3.2.5 Sterile Water for Inhalation
3.3 Nonmonographed Waters
3.3.1 Drinking Water

3.3.2 Other Nonmonographed Waters
3.3.3 Ammonia-Free Water
3.3.4 Carbon Dioxide-Free Water
3.3.5 Distilled Water
3.3.6 Freshly Distilled Water
3.3.7 Deionized Water
3.3.8 Deionized Distilled Water
3.3.9 Filtered Water
3.3.10 High-Purity Water
3.3.11 Deaerated Water
3.3.12 Oxygen-Free Water
3.3.13 Water for Bacterial Endotoxins Test
4. VALIDATION AND QUALIFICATION OF WATER PURIFICATION, STORAGE, AND DISTRIBUTION SYSTEMS
4.1 Validation Requirement

4.2 Validation Approach
4.2.1 Validation Elements

4.2.2 User Requirements Specification and Design Qualification
4.2.3 IQ
4.2.4 OQ
4.2.5 PQ
4.3 Operational Use
4.3.1 Monitoring
4.3.2 Validation Maintenance
4.3.3 Change Control
4.3.4 Periodic Review
5. DESIGN AND OPERATION OF PURIFIED WATER AND WATER FOR INJECTION SYSTEMS
5.1 Unit Operations Considerations
5.1.1 Prefiltration
5.1.2 Activated Carbon
5.1.3 Additives
5.1.4 Organic Scavengers
5.1.5 Softeners
5.1.6 Deionization
5.1.7 Reverse Osmosis
5.1.8 Ultrafiltration
5.1.9 Microbial-Retentive Filtration
5.1.10 Ultraviolet Light
5.1.11 Distillation
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5.1.12 Storage Tanks

5.1.13 Distribution Systems
5.1.14 Novel/Emerging Technologies
5.2 Installation, Materials of Construction, and Component Selection

5.3 Sanitization
5.3.1 Thermal Sanitization

5.3.2 Chemical Sanitization
5.3.3 UV Sanitization
5.3.4 Sanitization Procedures
5.4 Operation, Maintenance, and Control
5.4.1 Operating Procedures

5.4.2 Process Monitoring Program
5.4.3 Routine Microbial Control
5.4.4 Preventive Maintenance
5.4.5 Change Control
6. SAMPLING
6.1 Purposes and Procedures
6.1.1 PC Sampling
6.1.2 QC Sampling
6.2 Attributes and Sampling Locations
6.2.1 Chemical Attributes

6.2.2 Microbial Attributes
6.3 Validation Sampling Plans

6.4 Routine Sampling Plans
6.4.1 Source Water Sampling

6.4.2 Pretreatment and Purification System Sampling
6.4.3 Purified Water Distribution System Sampling
6.4.4 Water for Injection Distribution System Sampling
6.5 Non-Routine Sampling
7. CHEMICAL EVALUATIONS
7.1 Chemical Tests for Bulk Waters

7.2 Chemical Tests for Sterile Waters
7.3 Storage and Hold Times for Chemical Tests
7.3.1 Containers
7.3.2 Storage Time and Conditions
7.4 Elemental Impurities in Pharmaceutical Waters
8. MICROBIAL EVALUATIONS
8.1 Microorganism Types
8.1.1 Archaeans
8.1.2 Bacteria
8.1.2.1 Gram-Positive Bacteria

8.1.2.2 Gram-Negative Bacteria
8.1.2.3 Mycoplasma
8.1.3 Fungi
8.1.4 Viruses
8.1.5 Thermophiles
8.2 Biofilm Formation in Water Systems
8.2.1 Biofilm-Forming Bacteria in Water Systems

8.2.2 Non-Biofilm-Forming Bacteria in Water Systems
8.3 Microorganism Sources
8.3.1 Exogenous Contamination

8.3.2 Endogenous Contamination
8.4 Endotoxin
8.4.1 Sources
8.4.2 Removal and Control
8.5 Test Methods
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8.5.1 Microbial Enumeration Considerations

8.5.2 The Classical Cultural Approach
8.5.2.1 Growth Media

8.5.2.2 Incubation Conditions
8.5.2.3 Selection of Method Conditions
8.5.3 Suggested Classical Cultural Methods

8.5.4 Microbial Identification
8.5.5 Rapid Microbiological Methods
9. ALERT AND ACTION LEVELS AND SPECIFICATIONS
9.1 Introduction
9.2 Examples of Critical Parameter Measurements
9.3 Purpose of the Measurements
9.4 Defining Alert and Action Levels and Specifications
9.4.1 Alert Level

9.4.2 Action Level
9.4.3 Special Alert and Action Level Situations
9.4.4 Specifications
9.4.5 Source Water Control
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Page Information:
USP41-NF36 1S - 8674
USP41-NF36 - 7742
USP40-NF35 - 1852
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USP-NF https://online.uspnf.com/uspnf/document/GUID-07416921-813B-43A...

3.1 Bulk Monographed Waters and Steam

3.1.1 Purified Water

3.2 Sterile Monographed Waters

3.2.1 Sterile Purified Water

3.3 Nonmonographed Waters

3.3.1 Drinking Water

4. VALIDATION AND QUALIFICATION OF WATER PURIFICATION, STORAGE, AND DISTRIBUTION SYSTEMS

4.1 Validation Requirement

4.2.1 Validation Elements

4.3 Operational Use

5.1 Unit Operations Considerations

5.1.12 Storage Tanks

5.2 Installation, Materials of Construction, and Component Selection

5.3.1 Thermal Sanitization

5.4 Operation, Maintenance, and Control

5.4.1 Operating Procedures

6.1 Purposes and Procedures

6.2 Attributes and Sampling Locations

6.2.1 Chemical Attributes

6.3 Validation Sampling Plans

6.4.1 Source Water Sampling

6.5 Non-Routine Sampling

7.1 Chemical Tests for Bulk Waters

7.4 Elemental Impurities in Pharmaceutical Waters

8.1 Microorganism Types

8.1.2.1 Gram-Positive Bacteria

8.2 Biofilm Formation in Water Systems

8.2.1 Biofilm-Forming Bacteria in Water Systems

8.3 Microorganism Sources

8.3.1 Exogenous Contamination

8.5 Test Methods

8.5.1 Microbial Enumeration Considerations

8.5.2.1 Growth Media

8.5.3 Suggested Classical Cultural Methods

9. ALERT AND ACTION LEVELS AND SPECIFICATIONS

9.4.1 Alert Level

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