Validation Study and Quality Assurance of Pharmaceutical Water, Waterborne Microorganisms and Endotoxins
| Autor: | Hideharu Shintani |
|---|---|
| Rok vydání: | 2016 |
| Předmět: |
Microbiological Techniques
Quality Control 0301 basic medicine Validation study Drug Contamination 030106 microbiology Applied Microbiology and Biotechnology Water Purification 03 medical and health sciences Humans Technology Pharmaceutical Corrective and preventive action Bacteria Waste management business.industry Public Health Environmental and Occupational Health Water Alert level Purified water Endotoxins Action levels Environmental science Pharmaceutical manufacturing Water Microbiology business Quality assurance |
| Zdroj: | Biocontrol Science. 21:203-214 |
| ISSN: | 1884-0205 1342-4815 |
| DOI: | 10.4265/bio.21.203 |
| Popis: | Water for injection (WFI) and purified water are the most widely used and stringently regulated raw material in pharmaceutical manufacturing. WFI is utilized for a parenteral drug product. Water system is monitored at frequent and routine frequency for demonstrating the overall system control and stability of performance. The critical ports demonstrating systemic control should be monitored more frequently. For reducing the overall risk of microbial contamination or microbial build-up, it is important to develop appropriate alert and action levels. The assignment of alert and action levels should be performance-based, derived from the historic data and well below water specifications. These levels and overall excursion rates should be assessed annually. An action level should not be established at a level equivalent to the specification. Consecutive or multiple alert level excursions and each action level excursion should be comprehensively investigated with appropriate corrective and preventive action. It is important to analyze the efficacy of the corrective and preventive action to reduce the overall excursion rates. |
| Databáze: | OpenAIRE |
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