how to prepare SOP for AQL of core and uncoated tablets and capsule filling

Himanshu    |    23-08-2017

2 Answers:

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Himanshu    |    04-02-2018

Thanks a lot sir


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Mahak    |    03-02-2018

Hi Himanshu

To prepare the AQL procedure for uncoated tablets and capsule you can follow the below approach; Any sample evaluation should pass the following:

  • Sampling size should be appropriate and a representative sample of whole batch, you can collect the sample from initial, middle and end to cover entire batch and quantity can be decide based on some statistic tools (Poison distribution law)
  • Evaluation procedure or defect criteria must be define (Refer ISO 2859)
  • Success criteria should be define.
  • There must be normal & tighten AQL procedure.
  • Procedure should contain details if test is destructive then how will you handle this situation. There are some AQL where test is not destruction like ; visual verification of carton at terminal inspection.




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