TUNABLE ABSORBANCE DETECTOR
1) How is the IQ/OQ of your instrument important in the relation to validating methods that will be use the HPLC? Why is it important in the pharmaceutical industry that IQ/OQ is completely successfully on your type of instrument?
2) What additional IQ/OQ tests should be done on your HPLC module to make a complete IQ/OQ protocol? Describe a PQ test that would involve all 3 HPLC modules.
3) Now that you have executed a protocol, discuss what modifications you would make to improve the protocol you prepared for in Project II for your group leader. Be specific.
4) Discuss the whole process of the preparation and execution of IQ/OQ protocols. Discuss the importance of validation in the pharmaceutical industry, the need for and components of a Validation Master Plan and IQ/OQ is a critical part of both.