How to Determine Sampling Point for Powder Mixing Process

GOOD VALIDATION PRACTICE (cGVP) PROCESS VALIDATION
1

Dear all,
How do we determine sampling points for powder mixing and/or granulation process? Is there any reference for this? Thanks.

Regards,
Siswanto

2

Dear siswanto,
sampling point detemined on the basis of shape and size of equipment we decided the points which cover the maximum parts and space where the chance of mixing is less .

3

Dear Siswanto,

Please find the following URL for FDA’s draft guidance.

http://www.fda.gov/OHRMS/DOCKETS/98fr/03d-0493-gdl0001.pdf

Philix