Quality by Design Crossing Threshold from Development to Manufacturing
This article was originally published in The Gold Sheet
As quality by design goes commercial drug manufacturers struggle to translate concepts that made sense in the lab into processes that work in the manufacturing plant, they tell ISPE Washington conference PQLI session. The focus turns to training and communications challenges. FDA reviewers coach investigators on what to look for in a QbD inspection. Post-CMC pilot QbD applications roll in the door at FDA. The agency shares advice on crafting these submissions: Don't forget about 'residual risk.' Remember to maintain your design spaces. Keep in mind how the criticality determination process is evolving. Increasingly, design spaces are defined by models, but those models pose challenges to manufacturing equipment operators. The same goes for 'operationalizing' new QbD control strategies. The key: Get operations personnel involved.
You may also be interested in...
Counterfeits or substandard generics? Clash over definitions roils global anti-counterfeiting initiative. WHO IMPACT members divide over conflicting goals: protecting brands from counterfeits; protecting generics from being branded as counterfeits; and protecting emerging markets from substandard generics. Blowup over Dutch customs seizures. IMPACT begins to regroup as anti-counterfeiting regulatory landscape grows increasingly complex. U.S. pursues slow-tracked trace-and-trace; California e-pedigree stymied. The E.U. advances with pharmacy verification approach, registers a success with EFPIA pilot. Council of Europe works to criminalize counterfeit drugs. USP and AID minilabs would empower developing regulators. One third of antimalarials were substandard. Nigeria enables consumers to check for counterfeits by cell phone. Baxter takes layered approach. A pressing need for on-dose protection seen, but it must be covert. The day of mass serialization will arrive, but there will be no panacea.
Agency may share outcomes of remote record reviews in lieu of inspections at US and foreign facilities.