Page 10 - Contamination Control

GMP Training – Contamination Control in GMP Areas by www.gmpsop.com

within the facility and the air flow are important factors in controlling
contamination.

Just as important is the temperature and humidity within the facility. A facility

that is too hot or too humid rapidly causes operators to perspire and perspiring
operators are a source of particulate and microbial contamination. For these
reasons, processing rooms and storage areas should have controlled access.

The quality of air required in processing areas will be different for different
products and for different manufacturing stages of product.

Packaging department

Special emphasis needs to be given to the control of labels and pre-printed
packaging materials to prevent mix-ups and product recalls.

PACKAGING ROOM

Operators should observe requirements for
wearing clean working gowns.

Doors should be kept shut to prevent dust

and pests from entering.

Labels should be kept in an restricted area.
They should be kept in sealed containers and
returned to the store before the next
operation.

Never take personal medication into the
manufacturing areas.

Operations should be segregated and signs
should clearly identify the product being
packaged to prevent mix-ups.

Different products must be segregated.
Labels should be securely fixed to the
container – not the lid.

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