TUNABLE ABSORBANCE DETECTOR

? 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?

? 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.

? 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.

? 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.