C
Measurement of Uncertainty “as defined by the US Pharmacopeia”
Greetings all,
I have a problem.
Customer request: Measurement of uncertainty “as defined by the US Pharmacopeia”
Well, as I read it the USP is only dealing with the standard deviation. It does make reference to the type of weights used (in accordance with E617), however none of the other factors are used. I am aware this is something industry specific.
As I understand it, if I am going to issue a statement giving the MU of a particular device, I must include ALL of the variables.
The FDA in their enforcement of CGMP accept ANSI Z540 as an “acceptable standard.”
I can not find a document to prove it though.
How then do I prove 17025 is also an acceptable standard. I believe the phrase is “this standard is incorporated by USP by reference; other widely recognized standards may be acceptable” This refers to E617 only I think?
In my attempts to educate the customer (given my limited intellectual abilities) they seem to not understand what they are asking for. There also seems to be little or no understanding of 17025 or true uncertainty.
I have been through the USP, The CGMP part 7, CFR title 21 part 820, and sub 58.63.
I cannot find any DOCUMENTATION on what is and what is not Acceptable.
Can anyone help me prove any of this??
I am also in need of the current USP <41> and <1251>. I have not seen any revisions to the version I have regarding these two sections. I guess I need to prove that too.
Thanks…….
Greetings all,
I have a problem.
Customer request: Measurement of uncertainty “as defined by the US Pharmacopeia”
Well, as I read it the USP is only dealing with the standard deviation. It does make reference to the type of weights used (in accordance with E617), however none of the other factors are used. I am aware this is something industry specific.
As I understand it, if I am going to issue a statement giving the MU of a particular device, I must include ALL of the variables.
The FDA in their enforcement of CGMP accept ANSI Z540 as an “acceptable standard.”
I can not find a document to prove it though.
How then do I prove 17025 is also an acceptable standard. I believe the phrase is “this standard is incorporated by USP by reference; other widely recognized standards may be acceptable” This refers to E617 only I think?
In my attempts to educate the customer (given my limited intellectual abilities) they seem to not understand what they are asking for. There also seems to be little or no understanding of 17025 or true uncertainty.
I have been through the USP, The CGMP part 7, CFR title 21 part 820, and sub 58.63.
I cannot find any DOCUMENTATION on what is and what is not Acceptable.
Can anyone help me prove any of this??
I am also in need of the current USP <41> and <1251>. I have not seen any revisions to the version I have regarding these two sections. I guess I need to prove that too.
Thanks…….
