WHO Expert Committee on Specifications for Pharmaceutical Preparations - WHO Technical Report Series, No. 885 - Thirty-fifth Report
(1999; 168 pages) [Spanish] View the PDF document
Table of Contents
View the documentWHO Expert Committee on Specifications for Pharmaceutical Preparations
View the document1. Introduction
Open this folder and view contents2. The international pharmacopoeia and related issues
Open this folder and view contents3. International Chemical Reference Substances and Infrared Reference Spectra
Open this folder and view contents4. Quality control - national laboratories
Open this folder and view contents5. Good manufacturing practices
Open this folder and view contents6. Quality systems and inspection
Open this folder and view contents7. Other quality assurance topics
Open this folder and view contents8. Nomenclature and terminology
Open this folder and view contents9. Legal aspects of pharmaceuticals
Open this folder and view contents10. Regulatory issues
Open this folder and view contents11. Training activities
View the document12. Pharmaceuticals contaminated with diethylene glycol
View the documentAcknowledgements
View the documentReferences
View the documentAnnex 1. List of available International Chemical Reference Substances1
View the documentAnnex 2. List of available International Infrared Reference Spectra1
Open this folder and view contentsAnnex 3. General guidelines for the establishment, maintenance and distribution of chemical reference substances
Open this folder and view contentsAnnex 4. Good manufacturing practices: authorized person - role, functions and training
Close this folderAnnex 5. Good manufacturing practices: supplementary guidelines for the manufacture of pharmaceutical excipients
View the document1. General considerations
View the document2. Glossary
View the document3. Self-inspection and quality audits
Open this folder and view contents4. Equipment
Open this folder and view contents5. Materials
Open this folder and view contents6. Documentation
Close this folder7. Good practices in production and quality control
View the document7.1 Change control and process validation
Close this folder7.2 Good practices in production
View the document7.2.1 Prevention of cross-contamination
View the document7.2.2 In-process blending/mixing
View the document7.2.3 Control of microbial contamination
View the document7.2.4 Water systems/water quality
View the document7.2.5 Packaging operations
View the document7.2.6 Delivery
Open this folder and view contents7.3 Good practices in quality control
Open this folder and view contentsAnnex 6. Guidelines for inspection of drug distribution channels
View the documentAnnex 7. Good pharmacy practice in community and hospital pharmacy settings
Open this folder and view contentsAnnex 8. National drug regulatory legislation: guiding principles for small drug regulatory authorities
Open this folder and view contentsAnnex 9. Provisional guidelines for developing training programmes: inspection and examination of counterfeit pharmaceuticals
View the documentWorld Health Organization Technical Report Series
View the documentSelected WHO Publications of Related Interest
View the documentBack Cover
 
7.2.4 Water systems/water quality

While drinking-water is used for many excipient processes, purified water is also widely used. Because of the well-known potential for microbial growth in deionizers and ultrafiltration or reverse-osmosis systems used to produce purified water, such systems must be properly validated and checked. Proper control methods include the establishment of water quality specifications and corresponding action levels, remedial action when microbial levels are exceeded, and adequate maintenance procedures such as regeneration and sanitation/sterilization.

Appropriate specifications for chemical and microbial quality should be established and periodic testing conducted. Such specifications will vary depending on the process and the point in the process when the water is used. For example, in some cases, if the water is used in later processing steps such as for a final wash of the filter cake, or if the excipient is crystallized from an aqueous system, the water quality standards may need to be higher than normally specified for purified water. This is particularly important where the excipient's intended use is in parenteral dosage forms. The frequency of microbial and chemical testing of purified water depends on a variety of factors, including the test results and the point in the process (e.g. final wash in centrifuge) at which such water is used.

Most purified water and water for injection systems, including reverse-osmosis and ultrafiltration systems, have the potential for endotoxin contamination. If the final excipient is supposed to be pyrogen free or sterile, or will be used in preparing parenteral products, validation of the system to control endotoxins should be conducted and routine testing of the process water for endotoxins should be performed (preferably by the LAL (Limulus amoebocyte lysate) method).

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