The Quality Lowdown: ICH Q13 and Q14, Gene Therapy CMC, Drug Shortage Gaps, And An Excipient Misstep
ICH launches continuous manufacturing and analytical procedure guidelines while US FDA promises advice on gene therapy CMC, battles drug shortages and sees what went wrong with certain eye injections.
You may also be interested in...
McKesson meets with US FDA over opioid diversion warning letter, while UK MHRA takes risk-based approach to cross-contamination recalls and firm says it’s the other Guardian Pharmacy.
Drug compounding pharmacy Guardian Pharmacy Services was ordered to stop manufacturing sterile drugs after ignoring quality problems for too long, bringing to two the number of decrees the Justice Department has filed against drug compounding pharmacies so far this year, which at the current rate may exceed the two consent decrees filed in all of calendar year 2018. The action follows reports that patients administered eye injections of a drug compounded by Guardian during cataract surgery developed vision impairment.
ICH quality reflection paper outlines slate of guidelines to be adopted in near future, as well as a longer-term focus on training and implementation of its guidelines among a growing list of member countries around the world.