June 25, 2019

Out Of Specification Investigation Phase Ia & Phase Ib (MHRA)

Quality Control

Out Of Specification Investigation Phase Ia & Phase Ib (MHRA) Phase Ia Investigation Definition: Out of Specification Investigation Phase la investigation is to determine whether there has been a clear obvious errors due to external circumstances such as power failure or those that the analyst has detected prior to generating data such as spilling sample […]

Out Of Specification Investigation Phase Ia & Phase Ib (MHRA) Read More »

Out of Specification &Out of Trend Investigations (MHRA)

Quality Control

Out of Specification &Out of Trend Investigations (MHRA) Laboratory Analysis Investigations of “Out of Specification (OOS) / Out of Trend (OOT)/ Atypical results” have to be done in cases of: Batch release testing and testing of starting materials. In-Process Control testing: if data is used for batch calculations/decisions and if in a dossier and on

Out of Specification &Out of Trend Investigations (MHRA) Read More »