Definition In-House Reference Standards and Working Standards - Definitions

H

hkkim

#1
Hi, mate!

In the field of drug substance, especially for Standards,

What does " in-house reference standard" mean?

Does it mean a standard which is "prepared" or "manufactured" inside?

Does it differ from "working standard"?

I think "in-house" means used for inside, not originated inside...

However my colleagues define that "in-house" is "something made by ourself"... :argue:
 
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Stijloor

Staff member
Super Moderator
#2
Hi, mate!

In the field of drug substance, especially for Standards,

What does " in-house reference standard" mean?

Does it mean a standard which is "prepared" or "manufactured" inside?

Does it differ from "working standard"?

I think "in-house" means used for inside, not originated inside...

However my colleagues define that "in-house" is "something made by ourself"... :argue:


Help anyone?

Thank you!!

Stijloor.
 

Ajit Basrur

Staff member
Admin
#3
Hi, mate!

In the field of drug substance, especially for Standards,

What does " in-house reference standard" mean?

Does it mean a standard which is "prepared" or "manufactured" inside?

Does it differ from "working standard"?

I think "in-house" means used for inside, not originated inside...

However my colleagues define that "in-house" is "something made by ourself"... :argue:
There are 2 types of standards -

Reference Standard (also called as primary standard) - usually supplied by Pharmacopieal Authorities and no further qualification is required. They are official and traceable with Lot no, Certificate of characterization and expiry date.

Working standard (also called Secondary, Inhouse standard) and it must be qualified against a reference standard or primary standard. They are usually prepared In-house and qualified against the Reference standard.

Thus your inhouse standard could be from an internally manufactured batch characterized against the Primary standard.
 

John Broomfield

Staff member
Super Moderator
#4
Hi, mate!

In the field of drug substance, especially for Standards,

What does " in-house reference standard" mean?

Does it mean a standard which is "prepared" or "manufactured" inside?

Does it differ from "working standard"?

I think "in-house" means used for inside, not originated inside...

However my colleagues define that "in-house" is "something made by ourself"... :argue:
hkkim,

In a lab the Reference Standards would usually be traceable to national measurement standards so they can be used to verify the measurement (test method) internally.

A Working Standard would be a procedure (process) or specification (product) for monitoring the process or verifying the inputs/product.

John
 
H

hkkim

#5
There are 2 types of standards -

Reference Standard (also called as primary standard) - usually supplied by Pharmacopieal Authorities and no further qualification is required. They are official and traceable with Lot no, Certificate of characterization and expiry date.

Working standard (also called Secondary, Inhouse standard) and it must be qualified against a reference standard or primary standard. They are usually prepared In-house and qualified against the Reference standard.

Thus your inhouse standard could be from an internally manufactured batch characterized against the Primary standard.
The standard, which is manufactured inside, by synthesis or purification of API, very pure, fully qualified, can be classified "In-house Primary Reference Standard?"
Actually, I'm translating a SOP for management of Reference Standards from our language(asian) to English, my collegues made the draft, they made a classification for standards to 4 types. Reference standard(USP, EP) / In-house Primary reference standard(difined above) / Ex-house working standard(purchased Working Standard from raw material manufacturer) / In-house working standard(prepared W.S. in-house)......DO YOU THINK THAT DOES MAKE A SENSE???
I'm totally not understanding......Please give your opinion...
 

Ajit Basrur

Staff member
Admin
#6
The standard, which is manufactured inside, by synthesis or purification of API, very pure, fully qualified, can be classified "In-house Primary Reference Standard?"
Actually, I'm translating a SOP for management of Reference Standards from our language(asian) to English, my collegues made the draft, they made a classification for standards to 4 types. Reference standard(USP, EP) / In-house Primary reference standard(difined above) / Ex-house working standard(purchased Working Standard from raw material manufacturer) / In-house working standard(prepared W.S. in-house)......DO YOU THINK THAT DOES MAKE A SENSE???
I'm totally not understanding......Please give your opinion...
I am not sure ... have you checked the Pharmacopeias esp. USP <11> ?
 
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