We are all well conversant with the need/importance of 'investigation' and 'CAPA'; hence they will always be in place ; Further, FDA would not approve the product without appropriate reviews/acceptance criteria.
The point is
what is the approach of organization/industry-practices in handling these incidents/deviations.
1) are they (incidents/deviations) looked upon as learning processes towards establishing a robust process/product. (treat them as stepping stones)
OR
2) Are (incidents/deviations) looked upon as measure of R&D performance measure. (right first time, effectiveness of R&D processes etc.,--> practically speaking they are made to look like somebody's SIN!)
3) How to draw the line between above two approaches. (criteria and parameters )
[A quick note... here...
i) am referring to the 'tweaks' required to process/materials etc., during the tech.transfer and other operational problems/break downs are discounted
ii) tech.transfer... i am referring to the first few batches executed in the manufacturing environment which go towards filing/validations.]
The point is
what is the approach of organization
1) are they (incidents/deviations) looked upon as learning processes towards establishing a robust process/product. (treat them as stepping stones)
OR
2) Are (incidents/deviations) looked upon as measure of R&D performance measure. (right first time, effectiveness of R&D processes etc.,--> practically speaking they are made to look like somebody's SIN!)
3) How to draw the line between above two approaches. (criteria and parameters )
[A quick note... here...
i) am referring to the 'tweaks' required to process/materials etc., during the tech.transfer and other operational problems/break downs are discounted
ii) tech.transfer... i am referring to the first few batches executed in the manufacturing environment which go towards filing/validations.]
