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The News in Depth

EMA Updates Facility Inspection Procedures to Align with EU GMP Guide Revisions

The European Medicines Agency (EMA) has updated its GMP facility inspection procedures to align with recent revisions to its EU GMP Guide reflective of ICH Q8-10 principles....

Nanotechnology Under the Microscope at FDA

The rapidly expanding use of nanotechnology in therapeutic formulations is driving FDA to better define the regulatory and analytical framework needed to assess and address the potential concerns involved....

Particulates in Biotech Products: Standard Setting Effort Gaining Traction

Visible and sub-visible particles in parenteral products and the need for developing measurement standards is drawing attention from regulators and industry at biotech conferences....

Process Modeling in Focus for EU and US Reviewers

The understanding of the potential uses and value of models in facilitating manufacturers’ development efforts and helping regulators understand their complex processes is growing....

FDA Views Clinical Linkages as Key QbD Implementation Gap

As quality-by-design (QbD) implementation progresses, FDA is becoming aware of the scientific gaps that still need to be filled in. One area in particular that has generated considerable attention among industry and regulators is “understanding the link between what that product is and how it works in the patient – that is, integrating the field of biopharmaceutics into QbD,” ONDQA Acting Deputy Director Christine Moore stressed at a recent conference.

FDA Touting Benefits of Continuous Manufacturing

One area, in particular, that FDA is focusing on as a significant opportunity for advancing its quality-by-design objectives is continuous manufacturing. CDER officials’ have been highlighting their interest in continuous manufacturing at recent conferences, noting the recent progress that has been made in converting the concept into practice....

ICH Moves to Estonia in June: Heavy Metals, APIs, Implementing Q8-10 in Focus

ICH is gathering in Tallinn, Estonia in early June to focus on advancing its quality guidance harmonization initiatives on heavy metals (Q3D), drug substances (Q11), pharmacopeial methods (Q4B), and ICH Q8-10 implementation....

FDA Adjusts Its Pre-approval Inspection Guide To Reflect ICH Q8-10 Paradigm

FDA has updated its pre-approval inspection (PAI) compliance program guidance (CPG 7346.832) to better reflect the agency’s 21st century quality initiative and the new ICH Q8-10/QbD regulatory paradigm….

FDA Shares Concerns, Expectations Regarding Pharma Cargo Thefts

FDA sent a letter to medical companies expressing concern about the increase in cargo thefts of FDA-regulated drug products, and clarifying its expectations from companies and the agency’s role when thefts occur....

Draft Revision of EU Annex 2 For Biologicals Out For Comment

The European Commission has published a revised draft of Volume 4, Annex 2, “Manufacture of Biological Medicinal Substances and Products for Human Use.” This revision is taking place due in part to the need to include an increased range and complexity of biological products, and new products such as advanced therapy medicinal products....
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