Brief on GMP Guide for API (ICH Q7)

[@satishkumar-yp1sv]

Thank You Sir Providing lot of information to us

[@hitendrakumarshah3718]

It's my pleasure

[@VijayKumar-hs2uv]

During cleaning validation time, which samples should be collected first: swab samples for microbiology, rinse samples, or swab samples for chemical residuals?

[@hitendrakumarshah3718]

Normal practice is first swab for micro followed for chemical and then rinse. Because most of the time, rinse will be with organic solvent.

[@shetyeraj1]

According to ICH Q7 or other relevant guidelines, is it permissible to blend two continuous batches of API without testing the individual dried batches beforehand?

[@hitendrakumarshah3718]

That will be sub lots. These sub lots should be tested as per the respective specification (may not be finished specification)

[@satishkumar-yp1sv]

Please share the questions and answers

[@hitendrakumarshah3718]

You can refer the link shared in the description section