Page 14 - Contamination Control
P. 14
GMP Training – Contamination Control in GMP Areas by www.gmpsop.com
Rooms of this type usually contain a secondary extractor to collect the product
dust and sometimes filters on the return air vents and ducts. It is important
to keep doors shut, clean room and equipment regularly and maintain the
extraction systems.
Dry oral products, such as tablets and capsules, where bacteria or particles
are less of a problem, are usually processed in these rooms.
A pharmaceutical manufacturer had a product recall due to insecticide
contamination of a batch of tablets.
Several consumers had severe reactions due to the poisoning. Since insecticide
was not used in the plant, the company started a detailed investigation to trace
the source of the problem. The company rightly suspected that the problem was
one of foreign contamination.
Select what you think could be the possible sources of the problem. Explore each
possible explanation.
SOURCE OF PROBLEM
No, the company records indicated that no
insecticide was used or processed in the plant.
Possible, but the company was very careful not
to allow poisons into the factory. The pest
control company was escorted on site and not
permitted near processing rooms. They did spray
around storage rooms, however.
Copyright©www.gmpsop.com. All rights reserved
Unauthorized copying, publishing, transmission and distribution of any part of the content by electronic means are strictly prohibited.
Page 14 of 18
