For global Regulatory Affairs Directors.
A technology transfer can be the best decision for your manufacture – or, done wrong, it could be the worst. Our experts have identified 9 red flags to look out for before initiating a tech transfer.
1. No back-up manufacturing site
Preferably, do not initiate a tech transfer unless a back-up manufacturing site is guaranteed, in case the transfer is unsuccessful. This can lead to serious out of stock-situations.
2. History of deviations at accepting site
If the proposed site has a history of major deviations, FDA Warning Letters, etc. – this is a warning sign that there might be issues, also with future manufacturing.
3. High costs to meet requirements
If, for instance, costly bioequivalence studies are required for regulatory approval, the cost of the transfer might become higher than predicted, or even manageable.
4. Instability at leaving site
Stable formulation, manufacture and control at the leaving site is crucial for the transfer to be successful. If this is not secured, do not initiate a transfer.
5. Lack of support from leaving site
The leaving site must provide a robust support to accepting site in the transfer process. Compromised support means a high risk of the transfer being unsuccessful.
6. Missing quality agreements
Unless comprehensive quality agreements are in place, do not initiate a tech transfer. If (when) running into problems, clearly defined responsibilities are paramount.
7. Product not being marketed
Confirm with your marketing functions that the product to be transferred actually is going to be marketed!
8. Insufficient analytical method
Analytical method transfer needs to be secured before initiating any manufacturing activities. If the accepting site is unable to analyse the product, no transfer can be pursued.
9. Failed trial batches
Failed trial batches is an obvious sign that the accepting site is not capable of producing the desired product.
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