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High Foreign Inspection Failure Rate Indicates Need for Better Pharma Risk Modeling and Supplier Oversight Abroad, FDA Compliance Official Stresses

The current high FDA foreign inspection failure rate points to the need for the pharmaceutical industry to develop better risk models and intensify supplier oversight abroad, a senior official at the Center for Drug Evaluation and Research (CDER) Office of Compliance (OC) is stressing....

Health Canada to Release Inspection Findings

In late March, Health Canada announced that it would make its manufacturing facility inspection data public. The data will be presented in the form of an “inspection tracker” that will highlight the actions taken by Health Canada (request for quarantine, recall, or import restriction).

Chinese API Firm Found Non-Compliant

Following from an inspection in late January, the French National Agency for Medicines and Health Products Safety found Huzhou Sunflower Pharmaceutical to be non-compliant with GMPs. Twenty-seven deficiencies were observed, with those defined as critical or major being: ● particle contamination ● disposal of quality documents ● deficient water system ● multiple Certificates of Analysis […]

IPQ Monthly Update, January/February 2015

During January and February, IPQ explored several impactful initiatives that are underway in different areas of the pharmaceutical manufacturing and control arena to create standards and databases that will make both industry and regulators more effective and allow them to communicate better.  These include the efforts of: ● the industry-driven Allotrope Foundation to create lab data standards and the “lab of the future”● FDA in cooperation with industry to continue to implement the 2013 Drug Supply Chain Security Act ● regulators, industry and academia to upgrade pharmaceutical excipient databases, and ● Asian regulators, in line with those in the US and Europe, to address a new generation of regulatory challenges....

France Finds Data Integrity Issues at China Plant

Inspectors from the French National Agency for Medicines and Health Products Safety found North China Pharmaceutical Group Semisyntech’s Shijiazhuang plant to be non-compliant with GMPs in late January following an inspection in November. Inspectors cited manipulation of documents, data integrity in QC, contamination risk, change controls, and documentation management as the areas of concern.

Two Indian Plants Draw Non-Compliance Status in Europe

As posted in the Eudra GMDP database, the Italian Medicines Agency found Sri Krishna Pharma’s Hyderabad, India plant to be in non-compliance with GMPs in mid-December, following an inspection earlier in the month. The facility was cited for: ● lot rejection and using “trial” samples ● lab controls ● missing or poor quality agreement, and […]

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) […]

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.
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