if our hold time period establish for particular product is it necessary to perform re hold time study
when formula change or
change in equipment or
change in formulation or
change in manufacturing site
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Kindly update me answers
Dear ,
Formula- if major change —Yes should be done.
Equipment- Similar/equivalent- No need. for different-Yes,
Formulation- yes
Mfg site- Yes
Thanks
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If route of synthesis or majer equipments or critical parameters or ksm change then reperforming required
If you performed process validation for any applicable change, then hold time study to be carried out.
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on how many batches you perform hold time study
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Minimum 3 batches.
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One batch
Why one? do you have a risk analysis or something like that?
Typically one or more batches of the material, intermediate or product
can be used for determining hold times. A risk-based approach can be used to
determine the appropriate number of batches, considering the characteristics of
the materials and other relevant aspects. A representative sample of the batch
of material or product subjected to the hold-time study should be held for the
defined hold period. The hold period for each category of material should be
established on the basis of the study by keeping the material in either the original
or simulated container used in production. The containers in which hold-time
samples are stored should be the same pack as is used in production unless the
pack is exceptionally large, in which case one that is equivalent (constructed of
the same material and using the same closure system as the production packaging
system) may be used. Reducing the size of the container, when this is necessary for
testing holding time, should be justified.
Reference: WHO Guidelines, Annex 4, General guidance on hold-time studies WHO TRS 992-2015
Hi,
I would be grateful if somebody provide me with the hold time study report format in pdf.
Hi all.
Which acceptance criteria holding time testing should meet?
- Release specs
or - SL specs
I cannot find such info in guidelines
Released spec.
Thanks for the reply. Can I find this information in any official public guideline?
