Process validation of a tablet product

GOOD VALIDATION PRACTICE (cGVP) PROCESS VALIDATION
1

Hi,
I would like to ask everyone their opinion about critical quality attribute for granulation stage of a tablet and capsule product.
In particularly, I would like to know if you would consider uniformity of active or active content as a CQA at granulation stage. Based on that, do you believe uniformity of active or active content should be checked as part of process validation of a tablet or capsule product?

Also at the tableting stage, how do you decide on the frequency and number of tablets to be collected? Based on API % and the duration of tabletting? Can you please recommend any guidelines for this?

Thank you very much in advance

Best wishes

Carlos

2

Yes this is a part of CQA, for further detail let see ICH USP 29 Content Uniformity Test or Bergum 95-95 Testing
regard
M. Luqman

3

Search for “Powder Blends and Finished Dosage Units — Stratified In-Process Dosage Unit Sampling and Assessment”.

It is a non-binding draft guidance from FDA.

4

Hi,
Sorry due to busy unable to reply your Questionnaires,

  1. Generally, mixing uniformity, moisture content, flow and particle size distribution as a CQAs at granulation stage and uniformity of active or active uniformity is a part of blending and tableting stages.
  2. Above mentioned CQAs are parts of Process validation activities and sample size depends on %API, Batch size and Equipment size/shape.
  3. Justification will be based on Product Quality risk management activity under the reflection of ICH Q8,Q9 and Q10.

Thanks
Wish you all the best

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