The purpose of this SOP is to lay down a procedure describes the daily work plan of the laboratory. This SOP is applicable to routine and non-routine functions in Quality Control Department at manufacturing facility of Pharmaceutical Industry. PROCEDURE: Work shall be allotted to analyst for the day by the Section / Department Head, including […]
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The purpose of this SOP is to define the procedure for preparation, standardization and usage of working standard. This SOP is applicable to Quality Control Department at manufacturing facility of Pharmaceutical Industry. PROCEDURE: Precautions: Use clean and dry amber colored vials for storage of working standards. Store all Reference standards / impurity standards
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To provide detail procedure for Analyst qualification of Quality control analyst for the performance verification. This SOP is applicable for qualification of Quality Control analyst working in QC laboratory at manufacturing facility of Pharmaceutical Industry . PROCEDURE: All new joined analysts in the QC shall be qualified on the basis of accuracy,
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The purpose of this Standard Operating Procedure (SOP) is to lay down the procedure for defining job responsibilities of individuals. Objective : The purpose of this Standard Operating Procedure (SOP) is to lay down the procedure for defining job responsibilities of individuals. Scope : This SOP is applicable to all responsible persons of pharmaceutical Industry
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Objective To provide detail procedure for Analyst qualification of Quality control analyst for the performance verification. SCOPE: This SOP is applicable for qualification of Quality Control analyst working in QC laboratory at manufacturing facility. RESPONSIBILITY: Manager – Quality Control and Head of Quality assurance is responsible for the qualification of Quality control analyst.
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SOP ON Receipt, Issue & Control Of Lab Chemicals OBJECTIVE: The purpose of this SOP is to lay down a procedure for issue, control and disposal of lab chemicals. SCOPE: This SOP is applicable for issue, control and disposal of lab chemicals in Quality Control Department at manufacturing site. RESPONSIBILITY: Analyst / Section Head or
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SOP On Safety In Quality Control Laboratory OBJECTIVE: The purpose of this SOP is to lay down a procedure for describe safety aspects and precautions during working in the department. SCOPE: This SOP on Safety in Quality Control Laboratory is applicable for guidelines regarding safety hazards occurring during laboratory working and to guide on safe
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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 &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 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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