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Latest From Joanne Eglovitch
High projected cost and low perceived benefit merits further dialogue on US FDA's quality metrics initiative, industry coalition says. One group might tap into Trump administration's anti-regulatory view in advising budget office that compliance could cost industry $1bn per year. Groups question whether initiative could wind up causing drug shortages instead of preventing them.
A pharmaceutical industry official said while it is not too late, manufacturers that have not yet started risk assessments to comply with ICH Q3D for legacy products need to get busy. Official also advised that good risk assessments should make it easier to comply and reduce the need to retest products if new metals are introduced into the manufacturing process.
Complexity of manufacturing process for long-acting polymer-based injectable drugs, implants and in situ forming gels is delaying development of generic alternatives, but the US FDA hopes that new research into the formulation of these drugs will shed some light on how manufacturing processes can be replicated.
EMA proposes updating methods for water for injection; FDA clarifies policies on first responders under new drug tracing law; EDQM lists top 10 API deficiencies; and WHO invites API manufacturers to participate in prequalification program.
Recent US FDA drug GMP warning letters featured findings of lax contamination controls and data integrity issues at firms in China, India, Japan, Illinois and East Texas. Meanwhile, FDA hit six plants in India and China with drug GMP import alerts.
Despite the voluntary nature of US FDA’s program, an agency official urges full participation. Without data from such participation, FDA will not be able to predict drug shortages and industry will not see the benefits of reduced inspections and streamlined change control.