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GMP Documentation |
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Rules of Good Documentation Practice
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Laboratory notebooks usage |
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Logbooks entry |
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SOPs training |
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Reports writing |
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| 2. |
HPLC HP1050 with CHEMSTATION / CHEMSTORE (Rev.B.02.01) Software |
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2.1. Starting Chemstation software |
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System setup |
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Creating a method |
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Data acquisition |
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Displaying signals |
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Integration |
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Statistical Data analysis |
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Quantification |
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Basic report generation |
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2.2. Performing analysis on HPLC |
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Mobile phase preparation |
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Column care: Priming and equilibrating |
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Samples and standards preparation |
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System suitability |
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Loading a method |
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Run sequence |
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Data analyses |
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Integration |
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Report and results generations |
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Discussion of the results |
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| 3. |
Dissolution Testing analyzed
by UV-Vis Spectrophotometer |
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3.1. |
Dissolution Testing |
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Setting up the dissolution apparatus |
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Dissolution media preparation |
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Performing analyses |
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Sampling techniques |
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Sample preparation |
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3.2. |
UV-Vis Spectrophotometer |
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Setting up the equipment |
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Samples and standards preparation |
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Data acquisition |
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Software application |
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Report generation |
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Discussion of the results |
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Total class hours: 24Hrs (3
days) |
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| Options:
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Opt. #1: Proficiency Test |
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USP method perform on HPLC |
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Practical evaluation of the student’s
performance based on the test results from HPLC analysis. |
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Minimum passing grade 70% required
for Certificate issue. |
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Total class hours: 8Hrs (1day) |
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Opt. # 2: Troubleshooting |
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Pressure problems |
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Retention time & area precision |
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Baseline fluctuations |
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Peak shape problems |
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Total class hours: 8Hrs (1day) |
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| See also: |
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Advanced
Training Program » |
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Instrumental
Training Program » |
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