Dear Friends, During the process i have observed assigned cause (OOS) in the manufacturing investigation, with CAPA i initiated a change in the process and revised the BPR and done validation, the validation was failed because the change which i have made in the process. Now my question is i already obsolete the BPR and i want to continue the same BPR. How to justify this.
You can revert to earlier BPR by providing appropriate justification. However, by following old process again you may get OOS results. Therefore, this is a delicate issue. First try to find out the CAPA what you had suggested is a correct solution to the problem? Please perform thorough root cause analysis taking help of R & D (Formulation) to find out exact cause of product failure (OOS). It may happen that the reason of batch failure may be diferent and not BPR-process related.