Saturday, November 20, 2010
Instructions for supervision of analysis.
1.0 Purpose : To provide instructions for supervision of analysis.
2.0 Objective : To provide a documented procedure for supervision of analysis.
3.0 Scope : This procedure is applicable for supervision of analysis in QC department.
4.0 Responsibility :
· Primary: Officer – QA / Officer-Store
· Secondary: Officer – QA Manager.
· Spot-check once a week all registers, reagents and volumetric standard solutions.
· Frequently observe the actual testing done by the chemist.
· Review analytical reports and before signing check and confirm for:
· Complete entries in to the logbooks, test data sheets etc.
· Reagents should be stored in bottles.
· Reference / working standards stored in desiccators should be checked for details like name, date of preparation, date of expiry, purity.
· Whether analysis has been done as per the specified pharmacopoeia or in-house specifications (if specified).
· If not found to comply, necessary action to rectify / modify the procedure can be taken.
6.0 Reference Document : Not Applicable.
7.0 Abbreviations :
· QA = Quality Assurance
· SOP = Standard Operating Procedure
· QC = Quality Control
8.0 Copies to Distribution Sites. :
· QA –Ankleshwar
· QC – Ankleshwar