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May 18, 2013 – Related Posts Plugin for WordPress, Blogger… Follow Us … Rethinking emerging markets for regulatory affairs with the … European Medicines …

USP Delays Deadline for Industry to Comply With Elemental Impurity Standards

USP Delays Deadline for Industry to Comply With Elemental Impurity Standards

USP has decided to delay the implementation of two general chapters on elemental impurities until ICH has further established its own impurity testing requirements.

http://www.in-pharmatechnologist.com/Ingredients/USP-Delays-Deadline-for-Industry-to-Comply-With-Elemental-Impurity-Standards

EMA Updates Inspector Expectations for API Audits

EMA Updates Inspector Expectations for API Audits

As new API regulations are set in July for those outside the EU, the European Medicines Agency (EMA) has unveiled what its inspectors expect to see from API manufacturer or supplier audit reports from inside the region.

http://www.in-pharmatechnologist.com/Ingredients/EMA-Updates-Inspector-Expectations-for-API-Audits