Joanne S. Eglovitch
Senior Editor
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Latest From Joanne S. Eglovitch
PDA, ISPE Launch Quality Culture Effort With Root Cause Analysis Guide
Industry groups PDA and ISPE have banded together to produce a guide to help pharmaceutical manufacturers get a better handle on their deviations through choosing the right root cause analysis method and human factors studies.
Some Pointers From The US FDA On How To Conduct Better Out-Of-Spec Investigations
Industry is still having major problems in this area despite the FDA's exhaustive 2006 OOS guidance.
EU Guide Aims To Help Manufacturers Avoid Setting Off 'False Alarms' Under FMD
To reduce false alarms of counterfeits, EU tells drugmakers no lowercase, hyphens, question marks or certain letters in serial and batch numbers.
US FDA Warns Lupin Again About Poor Batch Failure Investigations
Agency demands review of invalidated out-of-specification findings as root causes of failures continue to elude Indian drugmaker at multiple facilities.
FDA Official Tells Industry How To Avoid Excipient Trip-Ups When Filing ANDAs
FDA official tells generics firms how to avoid letting excipient filing mistakes prompt ANDA derailments via refuse-to-receive letters.
FDA Sheds Light On How It Will Gauge Pharmaceutical Quality During Inspections
The US FDA announces plans to expand its new protocol-based approach to inspections, NIPP, to non-sterile drugs and provides glimpse of what metrics the agency is using to measure pharmaceutical quality during inspections.