Joanne S. Eglovitch
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Latest From Joanne S. Eglovitch
An upcoming PDA technical report is expected to build on the concepts of an earlier report on laboratory systems and propose a risk-based approach for protecting data integrity using a nine-box grid for assessing data integrity risks.
Firm should have addressed complaints of gritty topicals and compromised container/closures, and its own findings about overheated creams, the US FDA says.
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.
Industry is still having major problems in this area despite the FDA's exhaustive 2006 OOS guidance.
To reduce false alarms of counterfeits, EU tells drugmakers no lowercase, hyphens, question marks or certain letters in serial and batch numbers.
Agency demands review of invalidated out-of-specification findings as root causes of failures continue to elude Indian drugmaker at multiple facilities.