1.0 OBJECTIVE:To lay down the procedure for Planning for analysis and reporting of result.
2.0 SCOPE:This SOP shall be applicable to Quality Control Dept.
3.0 RESPONSIBILITY:Quality Control Supervisor
4.0 ACCOUNTABILITY:Sr. Manager Quality Assurance
5.1 Planning:5.1.1 Before starting the analysis, read carefully the directions given in the Specifications and Method of Analysis.
5.1.2 Ensure that all the details of the technique and the underlying basic principles are understood. In case of doubt, consult Quality Control Officer.
5.1.3 Plan the work in such a way that there is no hold-up at any stage. For example, any special reagents required for a test should be prepared before starting the test. Likewise, any dry glassware required should be available before the commencement of analysis.
5.1.4 Start with determinations that take a long time to complete.
5.1.5 Keep going two or more operations at the same time e.g. when a dish or crucible is drying in a desiccator, do a titration or weighing.
5.2.1 Carry out all analysis strictly according to documented procedures. Make no deviations in the quantities taken for the various tests or in the concentrations of the reagents used.
5.2.2 Do not amend any documented method and do not make corrections on the Specifications and Method of Analysis. If any amendment is necessary, inform the Q.C Officer who will validate the amendment, authorize it for use and document afresh the amended or modified test.
5.2.3 Restore to their proper places specifications after all the tests are over. Do not leave them on the workbenches and writing tables and in drawers of workbenches.
5.3 Reporting of Results:
5.3.1 Note all readings, weights, titres etc. directly on the pocket notebook and not on pieces of paper.
5.3.2 On analytical reports enter all the experimental observations and calculations on the calculation sheet. Record the conclusions on the front page. Exceptions are readings, which are to be reported directly e.g. Refractive index, pH, Colour, clarity of solution etc.
5.3.3 When a wrong entry has been made on the report, score it out with a single line and make the new entry alongside the original one and sign it. On no account should any overwriting on the original entry be done, at the same time it should be possible to read out the contents of stricken out matter.
5.3.4 Enter the dates on which the tests were done. When the analysis is spread over a period of time, note the actual dates on which the tests were done against the relevant test results.
5.3.5 Where replicate testing has been done enter all the results.
5.3.6 Record the final result of any test with only as many figures as will reflect the accuracy of the method of testing and as given in the relevant specification. For example, do not report a sulphate ash, loss on drying and assay to more than 2 decimal places. In all cases, calculate the result with all the figures and then discard the superfluous figures while reporting the results.
5.3.7 Enclose all document sheets and reports in plastic covers at the time of use in order to avoid soiling them.
5.3.8 Store all analytical records for five years.
6.0 ABBREVIATIONS:6.1 SOP : Standard Operating Procedure
6.2 QA : Quality Assurance
6.3 QC : Quality Control
6.4 Dept. : Department
Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
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