FDA warning letter of interest (media fills)
At the MS-Aubonne plant, a finished drug-manufacturing facility, FDA found several violations of cGMP.
They found that the company had not:
contamination of drug products purporting to be sterile.
- Established or followed appropriate written procedures for the handling of
- Established scientifically sound and appropriate specifications, standards, sampling plans,
and test procedures designed to assure that components, in-process materials, and drug products
conform to appropriate standards of identity, strength, quality, and purity Submitted
a Biological Product Deviation Report (BDPR) to FDA
and test procedures designed to assure that components, in-process materials, and drug products
conform to appropriate standards of identity, strength, quality, and purity Submitted
a Biological Product Deviation Report (BDPR) to FDA
- Reported changes to a product, production process, quality controls, equipment, or facilities.
In particular, relating to media fills, the company did not:
a. Not all personnel involved in the aseptic manufacturing and filling of sterile
drug products have participated in a media fill. Please note that media fill is a
critical evaluation of the process uses ability of aseptic processing personnel
to perform aseptic interventions, and their participation is essential.
drug products have participated in a media fill. Please note that media fill is a
critical evaluation of the process uses ability of aseptic processing personnel
to perform aseptic interventions, and their participation is essential.
b. Your firm lacks records to establish that aseptic processing
personnel performed interventions that are representative of the operation.
personnel performed interventions that are representative of the operation.
To view the letter: FDA
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