QC testing and release of excipients

Is it necessary for the manufacturer/laboratory in charge of QC testing and/or release for excipients to be GMP compliant?

Any manufacturer wanting to use excipients for the manufacturing of its medicinal product must test these excipients as part of its incoming goods inspection and release them for use in production. This testing and release of the excipients by the medicinal product manufacturer must be compliant with GMP. If this testing is sub-contracted to an external laboratory, the decision to release the excipient remains the responsibility of the manufacturer commissioning the tests. The manufacturer must also ensure that the external laboratory is adequately qualified, and it must ensure that testing of the excipients takes place in line with the applicable regulations. However, the external laboratory that conducts the testing of the excipients does not require a manufacturing licence from Swissmedic for this testing.

Your contact

Any questions?
I would be delighted to answer them.

Dr. Katharina Oehler
Scientific and Managing Director
T +41 44 787 70 20
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