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Batch Release

Discussions relating to Drug Laws

Batch Release

Postby Isadoro » Mon Dec 05, 2016 6:21 pm

Can we release API for use in manufacturing of batch without full analysis(Outside testing, provided that batch will not be released before complete analysis(Receipt and review of outside testing reports) Whether it is acceptable to have conditional release procedure and  is it acceptable by regulatory.
Isadoro
 
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Joined: Fri Mar 14, 2014 11:00 pm

Batch Release

Postby Jorge » Sat Dec 10, 2016 4:17 am

Can we release API for use in manufacturing of batch without full analysis(Outside testing, provided that batch will not be released before complete analysis(Receipt and review of outside testing reports) Whether it is acceptable to have conditional release procedure and  is it acceptable by regulatory.
Jorge
 
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Joined: Thu Feb 06, 2014 2:04 pm

Batch Release

Postby Darton » Mon Dec 12, 2016 8:30 am

The answer is "it depends".

If you are the API maker selling the API to a separate company, then for GMP and legal reasons the answer is "NO".

If you are a single company making both the API and the finished dosage form, the answer is "YES, BUT". The BUT is that:

a. the finished dosage is not released until the API is fully tested and released(and of course if the API fails testing, then the finished product cannot be released), and,

b. that this way of working is a very occasional practice(say no more than once a year)

I hope this helps.
Darton
 
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