Using multiple instrument for single validation

GOOD VALIDATION PRACTICE (cGVP) LABORATORY, METHOD AND ANALYTICAL VALIDATION
1

Hi,

Can anyone advise if it will be acceptable with the US and EU authorities if we do HPLC/GC method validation using multiple equipments for a single method.

Example, is it acceptable to do specificity, precision and linearity in one instrument and the other parameters like solution stability, accuracy, LOD, LOQ and robustness in a different but equivalent instrument for the same assay method validation.

What are the other factors to consider inaddition to similar instrument (model, make etc). This is regarding assay or related substances or residual solvents determination for API

Is there any query email for asking the US FDA regarding this.

Thanks

Arun :slight_smile:

2

In AMV, the method is not dependent on specific equipment, if u have different equipment u can use it , because in Precission reproducibilty, systemm and analyst should be change for analysis.

3

My dear Arun!

Yes u can validate a method for HPLC or GC using 2 HPLC or GC of same model or different model but the chromatographic condition shud be the same but tell me one thing y u want to go for multiple (equivalent) instrument y to take headach when a guidline says to just do robustness by changing instrument and analyst. i think u better do smart work and use 2 instrument thats enough to fulfill the acceptance criteria.

Regards,
Shahid Ali
QA Manager
Addis Pharmaceutical Factory SC, Ethiopia

4

hi,

for method validation I would recommend only 2 instruments be used.
2 analysts, 2 instruments and obviously the same conditions on each.
Also I would not recommend using 2 different models to validate one method.

Ruth

5

Well, Mr Ruth. y not to take two different model, i think it wud be more preferable coz ur method wud be considered robust to run it on different model of HPLC or GC, diffrent model doesnt mean the difference in basic principle of instruments. lets suppose if i agree with this same model and a method is validated on shimadzu HPLC it means method cant be used for Perkin elmer. anyway whatever model is the instrument shud meet the desired chromatographic conditions as per the method.

Regards,
Shahid Ali
QA Manager
APF SC, Ethiopia

6

Point taken, but where I work it is recommended to validate a method using one type of HPLC or GC. The reason is that we have only 2 type of HPLC (34 of one type and 6 of another) so as for this reason I am saying this. Also I think my name is confusing you, I am a Miss not Mr.

Regards,
Ruth

7

:slight_smile: well I m sorry Miss Ruth! i did not willingly call u Mr. anyway! u ppl have total 34+6=40 HPLC my God! its a huge instrumentation u ppl are dealing with. but the case is not the same for everyone. Organizations try to have different vendors to have competition and prompt after sales service. `Coz having all HPLC from same vendor is not wise and adviseable if some system fails and service is not available then it could b a great trouble, secondly a vendor cant black mail u for the service charges. yes if u have 2 or three different brands then your work wud never stop.

Regards,
Shahid Ali
QA Manager
APF SC, Ethiopia

8

Can anyone give us the details of water sampling and sampling point

9

Dear Dinesh
First define the study design and in water system validation protocol and mention a sampling plan and test period of 2-4 weeks in phase 1. Sample the incoming feed-water to verify its quality. Sample after each step in the purification process daily. Sample at each point of use and at other defined sampling points daily. Run phase 2 for another 2-4 weeks using the same sampling scheme.

10

Dear Dinesh,
The Basic strategy of water system is first to maintain the system under normal operating conditions during which frequent and extensive sampling and testing are performed in order to profile the system. To accomplish this, you have to designed the comprehensive validation study, which comprises three validation phases.

  1. Validation Phase I (Prospective)

  2. Validation Phase II (Concurrent)

  3. Validation Phase III ( Retrospective)

  4. VALIDATION PHASE I
    The performance of each major system component and all user points will be verified during phase I testing. This will be accomplished by sampling the system for entire one month and performing chemical analyses and microbiological evaluation on these samples.
    Daily sampling chemical and microbiological analyses of the feed water and inlet and outlet of each process devices in the system for evaluating the device effectiveness compared to its design specifications. After completion of successful results of phase I study, the water system will be ready for production and other domestic use.

  5. VALIDATION PHASE II
    Phase II is a continuation of phase I but with reduced sampling frequency (twice in a week). Phase II will be initiated only after the requirements stipulated in the phase I testing have been satisfied. The evaluation of sampling and testing of this phase will take three months. At any time, undesirable trend result will obtain then increase in sampling frequency and number of sampling location will be performed.

  6. VALIDATION PHASE III
    Phase III is a continuation of phase II but with reduced sampling frequency (once in a week).The evaluation of sampling and testing of this phase will take eight months. And data of entire one year including phase I and phase II data will presented graphically (trend analysis) and collecting the result as retrospective.

Thanks