Page 25 - Introduction QC

GMP Training – Introduction to Quality Control (QC) by www.gmpsop.com

materials, standards, and equipment needed

necessary safety precautions

detailed method (description of test, sample
preparation, instrument setup/conditions, test
run, and instrument shut down)

calculations and system suitability

change history

Structure of typical test methods

Laboratory test methods are critical documents that must be exactly followed
when performing a test, and are controlled and approved by management. Test
methods usually have the following features:

'Written By:" (test expert)

"Reviewed By:" (laboratory supervisor)

"Approved By:" (laboratory manager)

unique document number and revision code

document scope

safety notices

instruments and materials

system suitability limits

details of the method steps

how the results are calculated and recorded

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