Industry Resources
SOP Calibration Production Quality Control Regulatory Affairs Validation Quality Assurance Microbiology
The terms OOS, OOE and OOT are very important from the pharmaceutical Quality Assurance & Regulatory Affairs point of view and always emerge in connection with the handling of deviating analysis results.
Out-of-Specification (OOS) results: A [...]
Correction is an action taken to eliminate a detected nonconformity. Correction is like first-aid, it’s the instant action that is taken to correct the nonconformity or to reduce the impact nonconformity that has occurred.[...]
1.0 OBJECTIVE:
1.1 To lay down a procedure for receipt, registration, investigation, resolution, maintenance of records and closure of market compl[...]