A US-American pharmaceutical manufacturer has
recently received a Warning Letter from the
FDA due to deficiencies in packaging and
quality assurance. Complaints were made regarding
line clearance, cleaning of the equipment and
investigation of deviations. During the inspection,
which took place in February and March, the FDA noticed
inadequate line clearance.
The pharmaceutical manufacturer, who works as a
repackager, had indicated in batch records that the
line clearance had been carried out. However, the FDA
had actually noticed numerous tablets and capsules on
and below the packaging lines. The manufacturer had
indicated that they would improve line clearance and
re-train their staff. However, the FDA complained that
the response did not include an SOP for line clearance.
Another SOP for the cleaning of the production areas -
according to FDA - lacks necessary details.
FDA lacks evidence that product residues are sufficiently
removed from the multipurpose equipment. In its cleaning
validation, the manufacturer had used the most powdery
product and considered this to be a validation for other
products in a worst-case consideration. This is understandably
not sufficient for the FDA. The FDA now expects a cleaning
validation programme that addresses issues such as toxicity
of the products, solubility of the products in the cleaning
medium, products that are difficult to clean, definition of
wipe test points in the equipment that are difficult to clean
and maximum service life before cleaning is required again.