Month: June 2019

Out Of Specification Investigation Phase II (MHRA)

Out Of Specification Investigation Phase II (MHRA) Conducted when the phase I investigations did not  reveal an assignable laboratory error.  Phase II investigations are driven by written and approved instructions against hypothesis.  Prior to further testing a manufacturing investigation should be started to determine whether there was a possible manufacturing root cause. If not already …

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

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 …

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Out of Specification &Out of Trend Investigations (MHRA)

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 …

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SOP ON OPERATION AND CALIBRATION OF pH METER (QC)

SOP ON OPERATION AND CALIBRATION OF pH METER   OBJECTIVE:  The purpose of this Standard Operating Procedure (SOP) is to describe the procedure for Operation and Calibration of PH Meter. Make:……, Model: …….  ID No: …… SCOPE: This SOP is applicable to PH Meter in the Quality Control Department at Pharmaceutical manufacturing facility.   RESPONSIBILITY:   …

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SOP On Cleaning Of Incubators

SOP On Cleaning Of Incubators OBJECTIVE: The purpose of this SOP is to lay down the procedure for Cleaning of Incubators. SCOPE: This SOP is applicable used in microbiology for Cleaning of Incubators laboratory at of Pharmaceutical manufacturing facility. RESPONSIBILITY: Microbiologist or his designee shall be responsible for Cleaning of Incubators. The Head of Microbiology …

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