483 observation

summary of global nitrosamine regulations FDA, EMA, ANVISA, SWISSMEDC, HEALTHCANDA.

* Nitrosamines are trace chemical impurities. * They are classified as probable human carcinogens. * Global agencies require a strict…

3 weeks ago

Key FDA Updates (Late May–Early June 2026)

The FDA’s latest updates (June 2026) include several new drug approvals, safety warnings on hidden ingredients in supplements, and upcoming…

1 month ago

QMS – CAPA MODULE

STEP-BY-STEP PROCEDURE 1. PURPOSE To describe the steps for initiation, investigation, implementation, effectiveness check and closure of Corrective and Preventive…

1 month ago

Detailed Regulatory Nuances

1. EDQM / EU GMP (Europe) ​Focus: The European approach places heavy emphasis on the Qualified Person (QP). The QP…

7 months ago

Pilot batch sample has been taken to stability.

No Only manufacturing area or production batch taken as stability

3 years ago