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.

Cambridge Major expands

Cambridge Major expands

Cambridge Major Laboratories expects to complete construction of a
new process R&D and manufacturing facility in the middle of
2004 that will make it one of the largest Good Manufacturing
Practice (GMP) development and small-scale...

FDA planning GMP revamp

FDA planning GMP revamp

The US Food and Drug Administration is gearing up for the first
major overhaul of its current Good Manufacturing Practice
guidelines in 25 years, according to the agency's Commissioner Mark
McClellan. The move is just one strand...

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