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The News in Depth

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....

McNeil Voluntary Plant Shutdown, Product Recalls Follow FDA Inspection

On April 30, McNeil Consumer Healthcare, the OTC division of J & J, announced a recall of about 1,500 lots of liquid infant’s and children’s Tylenol, Motrin, Zyrtec and Benadryl, and voluntarily shut down the plant where they were manufactured at the end of a two-week FDA inspection at their Fort Washington, PA facility....

QbD is Changing the CMC Regulatory Landscape in the US and EU

The May 2010 issue of International Pharmaceutical Quality (IPQ) provides an in-depth analysis of how quality by design and the new Q8-10 regulatory paradigm is transforming the CMC review process at the agency and international levels....

Propofol Shortage Follows Teva and Hospira Warning Letters and Recalls

European manufacturer Fresnius is stepping in to help fill the US shortage in the injectible anaesthetic propofol caused by GMP problems at Teva and Hospira, resulting in warning letters and recalls. FDA's lengthy warning letter to TEVA in December, posted in April, focused on the manufacture of their generic version of propofol, and primarily related to microbial contamination and testing, including endotoxin in distributed product....

MHRA is Requiring Interim Update Reports for Risk-Based Inspections

MHRA is requesting that all manufacturing sites inspected after April 1, 2009 under its risk-based inspection (RBI) approach submit interim updates to communicate significant changes between inspections....
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