Under the proposed amendment, how is any microbial growth detected in a Grade A area to be treated?
- A.As an acceptable deviation if it stays within the tolerance limit
- B.As a trigger for investigation
- C.As ground for immediate cancellation of the manufacturing licence
- D.As a reason to re-sterilise the batch and release it without further action
Show answer
Besides revising the numerical limits, the draft adopts the World Health Organization position that the detection of any microbial growth in a Grade A area must itself set off an investigation, rather than being measured against a permitted level and passed over.
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