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PQ System and Protocol Design Objectives
The goal of any PQ should follow the previous shown IQ/OQ design plans. It should not be lost in the design of any
protocol that the PQ tests should be;
Easy to Perform
Reliable
A must for any PQ protocol should involve using an HPLC column in place and using a “typical” injection sequence
that the lab is already familiar with.
All PQ Protocols should include:
- Certified, NIST-traceable Analytical Solutions that are easy to use.
- A dedicated HPLC Column that gives the proper performance. It must be within defined specifications and must
produce the same results even after long term storage.
- The individual test procedures should all be written and must include documentation to properly validate and
prove the accuracy of the test.
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