Friday, 5 July 2019

SOP on Analyst Qualification


Purpose
This SOP describes the procedure for Analyst Qualification which are working in Analytical Development Lab.
Procedure:
  • Every analyst shall be qualified in their respective working area prior to assigning the responsibility individually, viz. Chemical analysis, Instrumental analysis.
  • Before starting analyst qualification, Manager, ADL/Designee shall ensure that the analyst is trained in Chemical analysis and instrument handling.
  • All instruments to be used for analysis shall be within calibration due date and the solutions/ reagents to be used shall be within their expiry date.
  • Analytical methods, which are to be used in analysis, shall be validated or official in pharmacopeia.
  • The sample to be provided for qualification shall be previously or parallel analyzed by competent personnel with same operating conditions like instruments, reagent solutions, working standards and other environmental conditions.
  • Manager, ADL/Designee shall decide the sample and test method for analyst qualification.
  • Manager, ADL/Designee shall give the analyst the sample with test protocol and the method of analysis.
  • Analyst shall perform the testing on the sample provided as per method of analysis in triplicate, including all solution preparation.
  • The test results obtained and the summary of results shall be recorded in the analyst qualification protocol.
  • All relevant data e.g. analysis report, chromatograms, raw data shall be attached to the analyst qualification protocol.
  • Manager, ADL/Designee shall review the report obtained along with the report from the parallel analysis done by competent analyst.
  • The acceptance criteria for analyst qualification shall depend upon the nature of individual test carried out.      
  • If the results obtained are not within the acceptable limits, then more training shall be imparted and re qualification shall be done.  
  • Frequency for re-qualification of the analyst shall be done after once in two years or in case of Out of Specification (OOS) investigation shows analyst error. 
  • After completion of the analyst qualification the activity shall be recorded in the analyst qualification protocol.


Rahul Kashyap is the executive in a Leading Pharma Company, he author in-depth guide that teach pharma industry owner and workers way to follow, manage and grow the quality work in this Field.

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