Dear all,
When the sampling time is met and we could not evaluate the sample yet, could we take the stability samples out from the stability chamber and then store in a refrigerator until we could evaluate them? Thanks in advance.
Regards,
Siswanto
When you remove that material you have a purpose.
Plan the evalution studies, remove and perform them.
Strorage in refregirators is only for short period of time that is 1 hour or so.
You cannot store for longer time.
If you store, you need to write deviation documents.
FDA is practically interested to look into log books how they are done.
Any change in climatic condions you will be caught on a wrong foot.
Plan, remove, perform and document.
Thats only way.
Regards
It is best to follow your written procedure on how to handle Stored Sample Material. It is always best to keep it at its storage condition until the last possible moment when the sample is actually needed for evaluation studies. Any change in storage conditions need to be noted and explained for short time periods and possibly deviation for longer periods.
Hope this is of some help.
Is there any literature or reference guidance? Thanks.
I think you can look ICH guidelines on this. They tell you how to do things right. The procedures you must write and evaluate and execute.
The stability samples shall not be keep long time under refrigeration condition, if you keep long time due to analytical load, the same shall be handled through deviation procedure and the in active time shall be calculated and study period shall be extended for cumulative in active time.
Thanks
[quote=syx]Dear all,
When the sampling time is met and we could not evaluate the sample yet, could we take the stability samples out from the stability chamber and then store in a refrigerator until we could evaluate them? Thanks in advance.
Regards,
Siswanto[/quote]
Dear Siswanto,
You can not remove samples from Stability Chambers and store in refrigerator. You should have SOP stating the period +/- from the actual due date of testing samples.In case you are not able to test even within this period due to some reasons,samples must be kept in Stability Chambers and should be removed only when you are ready for testing the same.( Generally within 1 hr. ). It is necessary to take deviation for the same.
Regards,
Dr.Barve
thanks for all responds…
thanks for the document. however, in indonesia we use storage condition 30C 75%RH for long term stability study, based on WHO TRS 953 Annex 2 Appendix 1.
For three validation batches kept on stability study (Long Term, Intermediate and Accelerated conditions), 2months stability data of accelrated is found satisfactory, suddenly stability chamber major failure is observed (not rectified 1 months), then where we have stored the samples, How to address the regulatory requiremnets with correct justification.
With regards
Petarge.B.S
Stability In-charge
Since you are addressing Validation Batches Stability Study programme you need to follow rules of
Deviations
Change control
Corrective actions
This will justify your regulatory cause.
You need to redo the accelerated stability study again and prove that product is stable as per packing and storage and there is no deviation from product quality.
[COLOR="#000000"]The change control process is initiated when a change is recommended proactively to resolve a specific product issue.
Change control activities may include a technology transfer for manufacturing and/or testing for those types of changes, raw material and API testing,equipment qualification, process validation, etc.
Once the stability evaluation is complete, the requirements are added to the change control along with other technical requirements, namely, testing, manufacturing, sampling, packaging, documentation, and quality requirements such as validation, IQ/OQ/PQ, batch disposition.
The change control is then circulated for review/approval to the appropriate individuals including QA and perhaps site management depending on the type of change.
Post-approval stability requirements should also be included in the change control documentation.[/color]
Thanks for valuable information
[quote=DURGA PRASAD][COLOR="#000000"]The change control process is initiated when a change is recommended proactively to resolve a specific product issue.
Change control activities may include a technology transfer for manufacturing and/or testing for those types of changes, raw material and API testing,equipment qualification, process validation, etc.
Once the stability evaluation is complete, the requirements are added to the change control along with other technical requirements, namely, testing, manufacturing, sampling, packaging, documentation, and quality requirements such as validation, IQ/OQ/PQ, batch disposition.
The change control is then circulated for review/approval to the appropriate individuals including QA and perhaps site management depending on the type of change.
Post-approval stability requirements should also be included in the change control documentation.[/color][/quote]
Dear all,
Can anyone share information on shelf life determination of drug product or retest date for Drug substances (Mathematical statistical equation for determination of proposed Shelf life and retest date.
Petarge.B.S
Stability in-chrage
The retest date formula when storage conditions are 25 °C/60%RH=
y=2X( x is below one year or equal to one year)
or Y=X+12 months(x is above one year )
Y=Retest date
x=long term stability data covered .
here x=24 months.
Y=24+12 months.
y=36 months.
The retest date formula when storage conditions are 5 °C(Refrigerator)
y=1.5X( x is below one year or equal to one year)
or Y=X+6 months(x is above one year )
Y=Retest date
x=long term stability data covered .
here x=24 months.
Y=24+6 months.
y=30 months.
Regards,
bujji Kanchi.
[COLOR="#000000"]Along with the API is combined with multiple formulas(combinations) of inert ingredients (excipients) to produce stability samples in tablet, liquid, gel, or ointment form, depending on the condition being treated and the most effective administration route for the patient. These ingredients dilute or modify the bulk volume of the product and charecterestics of the drug product being manufactured.
These excipients become an integral part of the product and may carry over into the storage life of product characteristics that provide the first line of defense against chemical change.
In such an event how do you measure the stability of these important ingredients other than antimicrobial preservatives?
An event of degradation of any one of these excipients will trigger the degradation of API in the product.
How to asses the rate of degradation of these excipients in various dosage forms like Tablets, Ointments, Powders, Injectables and liquid dosages?[/color]
[COLOR="#000000"]To be more precise on my question I would say there is a phase change from a tablet to Ointment to a Liquid.
How do you attribute degredation with a phase change. How the rates are affected?[/color]