Investigation into the causes of a medicinal product recall in connection with a new type of primary packaging material

Problems with the quality of a new type of primary packaging material for a new medicinal product arose after just a few months. Once the cause had been identified, additional GMP tests were carried out and changes were made to the machinery. The packaging process was re-qualified and subsequently re-validated. All the processes were measured and monitored. The primary packaging materials were checked and changes to the specifications were suggested.


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