28/29 April 2021
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.
The cleaning of the production equipment is also inadequate for the FDA. The 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.
The FDA also sees weaknesses in the company's Quality Unit. According to the FDA, the company's Quality Unit does not ensure adequate investigation of deviations in production. The FDA found 11 cases of deviations that had not been adequately investigated. Instead, the 11 batch records concerned were filed in a "Deviation" folder without a deviation form or investigation. Neither had the quality unit ensured that all production equipment had been qualified. For example, an air compressor used for production was not qualified.
Find more information in the original FDA Warning Letter to Coupler Enterprises