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New FDA Biotech Inspection Program Will Mine Ten Years of Industry Data to Enhance Targeting and Execution; Field Refining Risk Ranking Process Across Pharma Spectrum

The Center for Drug Evaluation and Research (CDER) is working to update its biotech inspection compliance program to make better use of the process, product, and compliance information it has collected from the industry in the decade since the previous version went into effect and better target its inspection efforts....

IPQ Monthly Update, November 2014

In focus are the structure, function and impact of two components of the new Office of Pharmaceutical Quality that will be on the front line of its industry/agency interactions: ● the Office of Program and Regulatory Operations (OPRO), which will play a pivotal role in CMC reviews, and ● the Office of Surveillance, which will be spearheading the agency’s effort to more coherently assess a company’s quality management. Included on the international front are stories on: ● how the Europe-based association APIC is mapping API requirements in emerging countries and working with them to make their processes more effective and user friendly, and ● IPEC’s efforts to narrow the excipient maker/user communication gap on visible particles....

ISPE Issues Definitions for Quality Metrics Pilot

In late October, ISPE released detailed definitions for the metrics it plans to use in its quality metrics pilot program. Those with consensus industry acceptance are: ● lot acceptance rate ● complaints rate (total and critical) ● confirmed OOS rate, and ● US recall events (total and by class). More metrics are also presented, as […]

Hospira Heparin Recall

A recall by Hospira of heparin in mid-September is the latest in a string of particulate-related recalls of Hospira injectables. Other of the firms products recalled for particulates over the past year include lidocaine, bupivacaine, and propofol.

Wockhardt Again Extends Metoprolol Recall

Wockhardt issued a third recall notice in late August adding additional lots to its recall of metoprolol tablets, manufactured at its Mumbai facility, due to the failure to meet dissolution specifications.

More Out-of-Compliance Sterile Drug Compounders

A warning letter and two alerts issued during July show FDA’s continuing crackdown on sterile practices at drug compounders, including inadequate sterility procedures, environmental monitoring and gowning (IPQ April 14, 2014). The warning letter was issued to Dallas-based Abrams Royal Pharmacy following an inspection in December. FDA also alerted healthcare professionals during July to avoid […]

Warning Letters from 2012 – Q1 2014 Show FDA’s GMP Enforcement Focus Shifting Overseas; Foreign Labs Draw Particular Attention

An analysis of FDA drug GMP warning letters issued since the beginning of 2012 highlights the agency’s increasing focus on enforcement outside the US – and on laboratory practices at foreign facilities, in particular....

Wave of FDA Warning Letters to Injectable Compounders in Q1 2014 Follows 2013 Inspection Blitz and Legislative Empowerment; Recipients Among Those Applying for Outsourcing Status

A bolus of FDA warning letters to injectable compounding operations in the first quarter of 2014 has followed in the wake of the agency’s 2013 inspection blitz of high-volume sterile pharmacy compounding operations nationwide and legislative empowerment through the Drug Quality and Safety Act (DQSA), signed into law in November....

CBER Focus Intensifying on Export Certification, Adverse Event Databases, and Lab Help in Product Development

Initiatives that will be on the front burner at the Center for Biologics Evaluation and Research (CBER) over the next year include: ● the completion of an electronic export certification system ● the increased use of databases to identify and confirm adverse events with vaccines and blood products, and ● using its extensive laboratory facilities and expertise to help in the development of novel products....

FDA Piloting Electronic FARs as Focus Intensifies on Defect Data Mining

FDA is piloting an electronic Field Alert Report (FAR) system that could help foster improved defect detection, prevention, and mitigation, and further empower the agency’s ability to understand where the industry shortfalls are and the particular firms that need heightened enforcement attention....
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