SOPs

[Consumer Products Guy]

Unfortunately, my QA and Regulatory are rearing their ugly heads again; does anyone have any generic SOPs on HPLC daily use or a source of such so I don't have to re-invent the wheel? They're not too comfortable with something that states to follow supplier's operating manual. I did see an Agilent SOP for 5890A GC use that was 168 pages, and for a non-computerized instrument at that.

[ravenwork]

For your industry, you might want to refer to the USP, United States Pharmacopeia. They tend to have reasonable, concise methods, and I am sure it will impress your QA wonks. I am not in that biz, or I could help you get some methods.

US EPA makes their methods readily available on the web, and they tend to be quite concise. You can check out www.epa.gov and probably find something useful.

ASTM might be another organization to investigate.

I recommend basing your SOP's off of the highly reviewed and carefully crafted methods available from these types of standard governing organizations.

Evan Cooper

[DR]

Refer to the specific methods for system suitability criteria. This will allow day-to-day use of systems. Youl will also need a SOP governing what happens when suitability failures occur, when and how to do calibration checks and maintenence issues (like - "I replaced a detector lamp, do I have to requalify the detector, the whole system ot what?"). It is also a good idea to track usage of columns and systems.