Process validation

Validation
1

please tell me how to do sampling in compression stage of tablet during process validation

2

at the start up of the compression process, in the middle and in the end

3

but i want to know is this must to take covering all tablet of no of station ex: if there is 27 station machine need to collect 27 tablet on LHS side and 27 on RHS side . or any other process??

4

Yes, you are absolutely right. During process validation you will have to collect at least number of tablets equal to number of stations on the compression machine so as to ensure that tablet compressed on every station has the physical parameters within the specification. It would be preferred to take 1 -2 tablets extra than number of stations on compression machine and also tablets from both the sides (RHS & LHS).
The frequency of collection of tablets also should be every 1 hour during compression which depends upon total run time of compression machine.
The composite sample should be prepared by collecting tablets from every one hour frequency for analysis of all parameters as per finished product specification.
During packing operation also similar strategy should be applied to conduct performance checks of packing operation such as Leak test, Sealing / Knurlling quality, Batch coding / embossing etc.
It has to be ensured that extensive sampling and close monitoring of process parameters (including Critical Process parameters-CPP and Quality Attributes (including Critical Quality Attributes - CQA) must be done during process validation than the manufacturing of regular batches.

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5

thanks for this brief explanation

6

You are welcome…

8

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