Page 6 - Contamination Control

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

GOOD TO KNOW - CONTROL OVER INCOMING GOODS

Incoming goods need to be controlled.
Each lot of material must be assigned a unique identification number to ensure

traceability and checked for possible transit damage and contamination.

Once these materials are accepted into the facility, they must be stored in such
a manner that contamination is minimized.

Before use, these materials must be checked for correct identity, cleanliness,
integrity of the storage container or protective wrapping and suitability for use
in the manufacturing process.

Only by these checks can operators satisfy themselves that the material has
not been contaminated during storage end is in fact the right material to be
using,

GOOD TO KNOW - USE OF COMPUTER SYSTEMS

Often computer systems are used to control inspection and test status, In this
case, materials and products may not have physical status labels or even be
stored in separate areas. Such systems must be validated and thoroughly
documented. All operators must be trained in the use of these systems.

Maintenance department

Poor housekeeping practices by maintenance personnel can cause problems in
manufacturing.

MAINTENANCE STORES

Operators should observe requirements for
wearing clean working gowns.

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