Good Manufacturing Practice

ICH clarifies Q7 guidance on API GMP manufacturing

ICH clarifies Q7 guidance on API GMP manufacturing

By Zachary Brennan

In response to a flood of requests over uncertainties regarding ICH Q7 guidance, the international consortium recently released a question and answer (Q&A) document intended help companies implement appropriate GMPs (good manufacturing practices)...

Contract Manufacturing Regulatory Approval Round-Up

Contract Manufacturing Regulatory Approval Round-Up

By Dan Stanton

Evonik gets the thumbs up from the MHRA, Recipharm's approved by Japan and Simcere passes the Chinese regulatory test – welcome to Outsourcing-Pharma’s round-up of GMP accreditation.

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