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Indian Agency Adding Inspectors

In late June, India’s Central Drug Standards Control Organization (CDSCO) announced that it will add 147 drug inspectors by the end of 2015 to shore up its GMP inspection capabilities, PharmaBiz reports. It notes that “CDSCO expects to double the manpower and enhance the lab infrastructure both at the center and states by the end […]

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....

Import Alert on Two More Ipca Labs Indian Facilities

In late March, FDA placed two more Ipca Labs’ facilities on import alert – formulation plants located in Pithampur and Silvassa, India. The company’s API facility in Ratlam, India was placed under import alert in late January (see IPQ “News in Brief” January 31, 2015). Ipca received a warning letter from FDA

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....

IPQ Monthly Update, December 2014

Headlining IPQ’s international coverage in December is the ICH Q12 effort to identify the constraints in the current quality regulatory paradigm to innovation and continual improvement across the product lifecycle and how it can be adjusted to remove them. Also in focus in the December issue are the structural and functional changes FDA is making to its center and field operations to address these constraints....

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....

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.

Canada Ban on Three APIs from India

In late September, Health Canada (HC) banned imports from two Apotex facilities, one API and one finished dosage form facility, and an IPCA Labs API facility, all located in India. The import ban comes as a response to data integrity issues revealed by the U.S. FDA. [For an in depth analysis of data integrity issues […]

Impax’ 483 in Taiwan Includes CoA Concern

A 483 issued to Impax Labs oral solid facility in Taiwan in late July underscores FDA’s current concern with overreliance on a component supplier’s certificate of analysis (see IPQ April 17, 2014 and July 27, 2014). Other of the 10 observations on the 483 address equipment validation, specification testing, rejection of OOS product, and process […]
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