Page 41 - Introduction QC
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GMP Training – Introduction to Quality Control (QC) by www.gmpsop.com
GOOD TO KNOW – A TYPICAL TEST METHOD LAYOUT
1.0 Policy and Definitions
2.0 Equipment and Materials
2.1 Equipment
2.2 Materials
3.0 Procedure
4.0 General Requirements
5.0 Test Method -Contents
5.1 Principal of the method
5.2 Materials list
5.2.1 Materials and reagents
5.2.2 Instrument description (including instrument settings)
5.3 Test Procedures
5.3.1 Preparation of standard solution
5.3.2 Preparation of sample and # of replicates required
5.3.3 Preparation of positive and negative controls
5.3.4 Test procedure and instrument settings
5.3.4.1 Instrument setting and preparation
5.3.4.1.1 Start up
5.3.4.1.2 Shut down
5.3.4.1.3 General operation
5.3.4.1.4 Data entry standards
5.3.4.1.5 Computer controls
5.3.4.2 Step-by-step procedure description
5.4 Reading the test endpoint
6.0 Calculations -include an example where warranted
7.0 Test acceptance criteria
7.1 Validity of the test -list system suitability criteria
7.2 Repeat testing
7.2.1 Invalid Test
7.2.2 Samples which fail specification
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