Prequalification of APIs - Indian Pharmaceutical Association
Prequalification of APIs - Indian Pharmaceutical Association
Prequalification of APIs - Indian Pharmaceutical Association
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Assessment <strong>of</strong> GMP<br />
An SRA is a medicines regulatory authority in a country that is:<br />
• a member <strong>of</strong> the ICH: Japan, USA, EU member; or<br />
• an ICH Observer, e.g. Swissmedic, Health Canada; or<br />
• associated with an ICH member through a legally binding mutual<br />
recognition agreement, e.g. Australia, Iceland, Liechtenstein,<br />
Norway…etc.<br />
32<br />
<strong>Prequalification</strong> <strong>of</strong> <strong>APIs</strong><br />
Mumbai September 2012
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