Manufacturer's Instructions

[Cliff]

I think I am guilty of "doing something the way I've always done it" or relying on old knowledge that has now been updated and I didn't keep up.

I thought there was an FDA requirement to follow the maintenance schedule listed in the manufacturer's instructions.  In reading 21 CFR 606.60, it seems all I need to do is develop my own SOPs.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=606.60

Thoughts?  What do you do at your facility?

I'd still like to follow the manufacturer's instructions.

Thanks

 

[John C. Staley]

I don't think you can go wrong following the manufacture's directions/recommendations!  Besides, it's easier than inventing your own.  The only time I would consider otherwise is if the manufacture's directions/recommendations are way over the top and burdensome.

[David Saikin]

I agree with John.

[AMcCord]

Agree with John also.

[jshepherd]

Same. Many of our SOPs refer to the manufacturer's manual for things, easier that way. 

[Ensis01]

Use manufacture instructions as your starting  point; but review and subsequently increase or decrease requirements as appropriate to your lab. 

[Auntie-D]

If you don't follow the manufacturer's instructions you have to validate, instead of verify for use - easier to use theirs...