Warning letter: falsified batch records and missing certificates of analysis

Many companies make use of the possibility of commissioning certain manufacturing steps. In doing so however, only the process is handed over to a contractor, not the responsibility. The product can only be finally released occur once the compliance with specifications has been proven by a contract laboratory.

During the inspection of a Mexican pharmaceutical company, FDA inspectors were confronted with the exact opposite: batches of a medicinal product were released without certificate of analysis by the contract laboratory. While the certificates had been found at some point during the inspection, the batches had obviously been distributed long before. The QS system had completely failed in this instance; it is therefore not surprising that further severe GMP violations came to light, which are described in the warning letter following the inspection:

No identity testing

Active pharmaceutical ingredients, starting materials and other components had been accepted without testing for identity upon receipt. Neither had they confirmed the analytical data provided in the suppliers' certificates of analysis (if available) by means of their own analyses.

Falsified batch records

The values for yields in the manufacturing process (weighing, filling, etc.) and label reconciliation had been entirely made up. The reason for this: there were no established calculations for determining yields.

No master production and control records

There were no master batch records for the manufacturing and in-process controls for the different batch sizes manufactured by the company. Calculations for required quantities of excipients had been performed on the spot - based on a wrong formula, at that. The batches had been released and distributed regardless.

The FDA placed the manufacturer's products on Import Alert on 12 July, 2017.

Source: FDA Warning Letter to Prosana Distribuciones SA de CV.

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