I have just recently been informed that the FDA is requiring API
manufactures to comply with the requirements for sterile drug product
manufacturing if the drug product is a sterile product. This is
regardless if the API manufacturer is not the one that performs the
formulation of the API into the finished drug product.
They told me of two different companies that received 483s with
numerous citations referenced to the sterile manufacturing guidance
of 2004. >From what I gathered, the two companies had Class 100K
rooms and their controls showed the particle counts to meet lower
classifications and so did their viables. The FDA auditors decided
to push the envelope and told them their controls where in-line with
aseptic operations and, even though the manufacturers never claimed
or intended to be a sterile operation, the FDA said they will be.
Anybody knows more about this?
Thanks in advance!
Miguel D. Castellanos
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