It is generally acceptable to mix two API lots from the same supplier and with the same specifications in order to produce a single FDF (finished drug product) lot, as long as the mixing process is controlled and validated. However, the regulatory authorities in the EU have the final say on whether this is acceptable for your specific product and study.
It is important to ensure that the two lots are compatible and that the mixing process does not affect the quality or safety of the final product. You should also consult your company's standard operating procedures (SOPs) and any relevant guidelines from regulatory authorities to ensure that you are following the appropriate processes and regulations.
Additionally, you should inform the regulatory authorities and the ethics committee in charge of the study, regarding the mix of the two lots, and provide them with the justification and validation of the mixing process.
It is also recommended that you retain samples of each lot before and after mixing, in case a future investigation is required.
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Edward Panek
VP, QA/RA
Med Device
USN Veteran
Research into Neural Nets -
https://www.twitch.tv/edosani------------------------------
Original Message:
Sent: 11-Jan-2023 11:51
From: Valeria Shkuratova
Subject: Mixing API lots for clinical batch manufacturing
Hello Everyone,
Our company is looking to manufacture a clinical lot for a study to be conducted in EU.
I would like to confirm, if we can mix two API lots (same supplier, same specs but one is the leftover from the previous campaign and the other half from the newly purchased lot) to produce one FDF lot?
Thank you )
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Valeria
Canada
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