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Are you reusing containers?

A company recently received this 483 observation: 

….. Equipment and utensils are not cleaned and maintained at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the drug product.

Specifically, many raw material containers are used to hold other various chemicals. According to your Facility Manager, any container can be re-used. These containers are cleaned with … to be re-used to store raw materials, and to hold drug ‘in-process’ product. There is no cleaning validation or other documentation to show this is adequate.

For more observations pertaining to device manufacturing controls see Issue 1027 available today.  It also has observations pertaining to manufacturing controls, laboratory controls and sterile manufacturing controls.

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