Contamination from Materials

All materials brought into a microbiologically controlled environment are potential sources of contamination. Any microorganisms can be associated with undefined materials. It is impossible to make a general assessment of risk from these sources, except to distinguish materials of plant, animal or silicaceous origin as being more likely sources of contamination than materials produced by chemical synthesis.

It is good practice for all materials and their manufacture to have been evaluated by audit (for their potential to contaminate pharmaceutical manufacturing clean rooms), but it may not be practical or economically possible to avoid contamination from such sources. Microbiological monitoring programmes should be operated to ensure that the pharmaceutical manufacturing facility is not exposed to the worst excesses of these potential sources of contamination. Suspect materials should be monitored on the basis of every incoming batch, but this need not necessarily apply to all materials, particularly synthetic chemicals.

Contamination of materials in transit and warehousing should be considered. Water and other damage to external packaging is particularly relevant, and should be referred to the department with the expertise to make a professional analysis of the risk to the product. This is usually Microbiological Quality Assurance (MQA).

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