QP declaration form for foreign manufacturers

How do you complete the QP declaration form correctly if the manufacturer of the active pharmaceutical ingredient and the manufacturer of the drug product are identical?

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.

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Any questions?
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Dr. Katharina Oehler
Scientific and Managing Director

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