Common Root Cause for Failures in Scaleup & Commercial (Validation) Batches

[v9991]

New Products - What are the common areas & root-cause for failures you faced in in scale up and commercial (validation) batches of new products.

[v9991]

common root cause for failures in scaleup&commercial(validation)batches new products
what are the common areas&root-cause for failures you faced in in scale up and commercial(validation) batches of new products.

[v9991]

current tally is as follows...
inadequate/inaccurate design (25%)
stability studies (25%)
input controls (13%)
inprocess controls-spec (13%)
fp spec (13%)
dynamic customer/market requirements (13%)

50% of the causes indicate the effectiveness of development processes!!!
another 26% attributed in-process and fp specification controls.

1) does it reflect the industry benchmark success rate of R&D process development?
2) what are the common and effective response to improve the above conditions employed at respective sites?

other 26% of input controls and dynamic market requirements are quite external in nature; yes, the input controls are partly governed by internal processes such as QC and vendor qualificatoin;