By nbpr on Tuesday, May 27, 2003 - 08:41 am:
A simple question regarding averaging:
If I have two sample preparations it will be correct to average both samples if one of them is out of specifications.
By David Blais on Tuesday, May 27, 2003 - 09:11 am:
It depends on your department SOPs. If the method (or another SOP regarding reporting of results) allows you to average two preps together, even if one is out of specification, then go ahead. Personally, I don't consider it good practice to average two preps if one is out of spec.
By Anonymous on Tuesday, May 27, 2003 - 12:59 pm:
Make some replicates, and see whats right, and what's wrong, probably you can determ one of them as an outlier.
By Anonymous on Wednesday, May 28, 2003 - 01:28 am:
Here is some good points about averaging under GMP:
http://www.fda.gov/cder/guidance/1212dft.pdf
generally not a good idea, unless you can't justify it for example by saying you have a variable method and you need to do some averaging to get reliable result. In other case individual OOS result means you have OOS product.