Page 15 - Contamination Control

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

No, unless the supply company made a horrible
mistake. However, the company did not check

the cleaning agent drums on receipt.

Possible, but the company was very careful to
conduct identity tests on all new materials
before use. Not every container was tested,
however.

No, the product had a tamper-evident seal, and

the severe reactions were in different regions.

Possible, the company did not use drum liner

bags, and the bulk product was in direct contact
with the inside surface of the 44 gallons storage
drums.

What actually happened

The drug maker used 44 gallon drums to store bulk powder. These drums were
supplied and recycled by a drum supplier. Among the drum supplier's customers
was an insecticide manufacturer. This was not known to the drug maker because
they had not audited the drum supplier's operations. The drum supplier did not
keep a separate stock of drums for the drug manufacturer, and did not have a
cleaning program for recycling.

Investigation also revealed that drum bag liners were not used, nor did the drug
maker have a program to inspect or clean the drums before their use in the plant
and. reasonably, their QC testing did not check for insecticide contamination.

When contaminated drums were returned by the insecticide manufacturer and
recycled via the drum supplier to the drug maker, the problem remained
undetected.

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