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

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

  • Product/process design is inaccurate or inadequate...

    Votes: 2 66.7%
  • Raw/input material controls are inadequate/inaccurate (QC / vendor qualification...)

    Votes: 1 33.3%
  • In-process controls/specification is inadequate or inaccurate...

    Votes: 1 33.3%
  • Finished product specifications is inadequate or inaccurate...

    Votes: 1 33.3%
  • Stability studies are not adequately established...

    Votes: 1 33.3%
  • Dynamic market/customer/regulatory requiremets...

    Votes: 0 0.0%

  • Total voters
    3
  • Poll closed .

v9991

Trusted Information Resource
#1
New Products - What are the common areas & root-cause for failures you faced in in scale up and commercial (validation) batches of new products.
 
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v9991

Trusted Information Resource
#2
common root cause for failures in scaleup&commercial(validation)batches new products

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.
 
Last edited:

v9991

Trusted Information Resource
#3
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;
 
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