Dear Ambika,
- Please refer BP General Notices Part II
The term 'competent authority' means the national,
supranational or international body or organisation vested with the
authority for making decisions concerning the issue in question. It
may, for example, be a licensing authority or an official control
laboratory.
- For impurities refer ICH Q3 A for drug substances and Q3
B for drug product.
Kind Regards,
Bhavesh L. Patel
Quality Assurance Dept.
Reliance Life Sciences Pvt Ltd,
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