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Notice on India’s Regulatory Procedures

Following from a meeting discussing Indian regulatory standards, India’s Central Drugs Standard Control Organization (CDSCO) issued a notice in early August to all of India’s state drug controllers on the standards for conducting GMP inspections. Of note is the need for focus on using a risk-based approach for inspections of product development, quality, stability, process […]

Success of Eight-Year Amgen Effort to Improve Deviation Investigations and Follow-up Actions Writ Large on Quality Metrics and Bottom Line

The results of an eight-year program at Amgen to improve its deviation investigations and follow-up actions demonstrate how concentrating on finding and addressing root causes can have a substantial impact on a firm’s quality assurance and bottom-line....

FDA Data Integrity Concerns Continue in India as Three More Firms Draw GMP Warning Letters

Three warning letters recently issued on findings at facilities in India indicate FDA’s continued focus on data integrity as a central concern of its international inspection program – and in the Indian arena, in particular....

FDA Seeking Industry Input on Quality Metrics to Help Rationalize Its Review and Inspection System

FDA is proposing that the application of the right quality metrics could help create a more flexible and rationalized review and inspection system and is asking for industry input on what metrics would provide the most effective leverage....

EMA GMP Chapter Draft Revisions Focus on Current Compliance Focal Points from Shared Facilities to Defect Investigations

The European Medicines Agency (EMA) has released draft revisions of four of its GMP chapters, intended to communicate its expectations regarding current compliance focal points including supply chain oversight, shared facilities, starting materials, lab method transfers, and investigating and reporting quality defects....

New FDA Field Alert Report System Provides for Electronic Submission and Unique Identifiers

FDA is upgrading its field alert report (FAR) system to provide for secure electronic submission of the reports, simultaneous transmittal to the appropriate district office and the Center for Drug Evaluation and Research (CDER), and unique identifiers for each report....

FDA Field Alert Reports Required for Anomalies That Occur During Distribution

FDA expects firms to submit field alert reports (FARs) for recurring technical defects discovered through the complaint process even when there is no evidence of the issues in site production records or retained samples....

FDA-Wide Effort Underway to Clarify and Harmonize CAPA Definitions in Line with New GHTF Guide

FDA Center for Devices and Radiological Health (CDRH) GMP expert Kimberly Trautman is spearheading an effort to clean up and harmonize the definitions around corrective and preventive action (CAPA) across the agency in line with a Global Harmonization Task Force (GHTF) guideline on CAPA that is nearing release....

IPQ Special Report — May/June 2009

ANALYSIS OF FDA AND EU GMP ENFORCEMENT ACTIVITY shows inadequate investigation of manufacturing and product nonconformances to be the most pressing concern on both sides of the Atlantic. FDA warning letters and injunctions are frequently linking GMP problems with the manufacturing of products that do not have the required new drug approval or do not […]

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CLICK HERE  for the IPQ Monthly Update – November/December 2020 in Review


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