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Canada Places Products from Two Indian Manufacturers Under Quarantine

Health Canada requested products from two Indian manufacturers, Dr. Reddy’s and IPCA Labs, be placed under quarantine in late December due to data integrity concerns. To date, no products from these manufacturers have been deemed medically necessary in Canada.

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....

FY 2014 FDA 483 Data Summary

FDA has released a summary of the data on form 483s issued in FY 2014. 645 483s were issued for drugs, 146 for biologics, and 337 for veterinary medicines. Most frequently cited for drugs was QC unit procedures (21 CFR 211.22(d)) with 145 observations, followed by lab controls (211.160(b)) with 109, and failure investigations (211.192) […]

Consent Decree at Compounder Main Street Family Pharmacy

In early December, FDA completed legal actions against compounding pharmacy “Main Street Family Pharmacy” that followed from mid-2013 FDA inspection findings of insanitary conditions and numerous other deviations from cGMPs. The company and its co-owner pleaded guilty to misdemeanor criminal violations of the FD&C act and entered into a civil consent decree

EU Ban On Ranbaxy Antibiotic Injectables

In early December, the EU banned imports from a Ranbaxy facility that makes injectable antibiotics after the unit failed an inspection. The Dewas plant unit did not meet EU GMP standards, Ranbaxy said in a stock market filing on Thursday, while all other units at the facility were approved. All exports to the US from […]

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....

MHRA Lists Top Deficiencies for 2013

In October, MHRA released a list of its top observed GMP deficiencies from 2013. The top five are: ● investigation of anomalies ● quality management ● CAPA ● contamination, and ● supplier audit – with the last two being tied for frequency.

CDER’s Office of Surveillance Will Oversee Expanding FDA’s QA Assessment Capabilities and Reshaping Inspections

The analysis that FDA’s Center for Drug Evaluation and Research (CDER) is conducting to lay the foundation for a more comprehensive assessment of a manufacturer’s quality assurance (QA) capabilities is showing that the results of one inspection are not a reliable predictor of the outcome of a subsequent inspection at the same facility....

FDA Revokes Approval for Ranbaxy Generics; Ranbaxy Sues

FDA revoked its 2008 approvals of Ranbaxy’s generic Nexium and Valcyte in early November, following import bans that were placed on the company’s Indian plants after finding them to be non-GMP compliant. Ranbaxy responded to the Nov. FDA action with a suit, stating that the agency had no right to revoke past approvals.

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 […]
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