Validation of a chromatographyc method

[Anna Arag]

Hello.
I'm new in this forum. I usually work in liquid chromatogrphy TDM (antiretroviral drugs), but now,we wont to begin with stability studies.
My question is: if there is an stability- indicating method developed in bibliography, and we reproduce exactly this method. Must we validate completly the method? what have we to do?
Could anyone help me?

Thank you

Anna

[philippem]

Hi Anna,

If you want to start with stability studies on drugs, you could look for info on the ICH website , especially the Q1 series of documents; this wil give you usefull information.
But first of all ,if you start with stability studies, you should have had your analytical method validated. Guidance on this subject can be found in the ICH Q2.
Attention should be given to the degradation compounds and proper identification and quantification of these compounds.
Accelerated test should be done inorder to identify possible degradation compounds.
I speak from experience !

succes

Philippe

[Rob Burgess]

Hi Anna and welcome to the forum -

Good question here and I'm not totally sure to be honest. My gut instinct would say you would have to validate for your companies "particular" product to ensure specificty. for instance, you may be using different excipients or grades of drug substance, compared to the original intended monograph. However hopefully the method will be suitable for you as a good starting point.

Good luck....

[Anna Arag]

Thank you two very much

We'll look for these ICH guidances.


Bye

[Bruce Hamilton]

The major issue with stability studies is that money is not thrown at testing until several important criteria are met, some of which are:-
1. The production process is finalised ( because impurities and degradation pathways may change )
2. The analytical procedures have been validated ( if the procedures can not detect degradation products or changes in the API or excipients, testing is useless ).
3. The stability test programme is approved in advance, and equipment is compliant, qualified and available ( otherwise the data will be rejected at Quality review ).

The ICH Quality series has expanded quite a bit over the last couple fo years. For product development and testing, it's no longer simply a matter of following the appropriate Q1, Q2, Q3, etc. guideline.

The programme now has to have the context of Q8 ( development ), Q9 ( risk ), and Q10 ( quality system ) - which are also available at the ICH site. Your quality people should have ensured that these guidelines are complied with before starting any testing.

They are not more onerous than most national regulatory requirements, and mainly affect the initial conception and planning of the programme and the quality systems that have to be in place.

They probably represent the belated industry recognition of the value of the global quality systems used in ISO 9000 and 17025.

Please keep having fun,

Bruce Hamilton

[Anna Arag]

Hello

Thanks to all for your advices.

I work in a hospital, and what we would like to do is to assess the stability of a drug ( concretely Interferon alpha 2b) under the storage conditions of the Pharmacy Service, taking as a criterium of non stability a loss of more or equal than 5 % in concentrations refered to a determination taken in time zero of reconstitution.
I'm going revise all these documents.

thank you very much

Best wishes
Anna