If the manufacturer of the active pharmaceutical ingredient and the manufacturer of the drug product are identical, Swissmedic will accept a single form confirming GMP compliance for both the active pharmaceutical ingredient and the drug product. This form must include the corresponding data for both the active pharmaceutical ingredient and the drug product. If two different dates are provided in Part C in the case of different audit reports (active pharmaceutical ingredient and drug product), Swissmedic will also accept this.
Dr. Katharina Oehler
Scientific and Managing Director
Send email