Lessons from pharmaceutical laboratory related FDA warning letters - Huber
Lessons from Pharmaceutical Laboratory related FDA Warning Letters
The Agilent Critical Compliance Seminar 2016
Ludwig Huber Ludwig_huber@
Overview
? FDA Inspections and reports ? GMP compliance along the sample and data
workflow ? Recent FDA warning letters & 483s and
recommendations how to avoid FDA warning letters related to ? Requirements for quality systems ? Requirements for workflow steps ? Responding to Warning Letters and 483's ? Resources
? Copyright
Ludwig Huber - LabCompliance
Slide 2
FDA Inspection Documentation
? 483 Form Inspection Observation ? only deviations listed ? written for inspection exit meeting
? Establishment Inspection Report (EIR) ? very detailed (20-40 pages) ? more like an inspection protocol
? Warning letter ? With significant deviations ? Reviewed by FDA centers
For examples, please check:
? Copyright
Ludwig Huber - LabCompliance
Slide 3
What about Europe
? EMA launched new version of the EudraGMDP website
? Incudes statements of non-compliance with GMP and positive GMP certificates
? Information includes company name, location, issue date, nature of no-compliance and the action taken by issuing authority in order to protect public health
? Examples for actions taken
? Withdrawal of current valid GMP certificate number
? Batch recall
013/12/news_detail_001994.jsp&mid=WC0b01ac058004d5c1#press-release
? Copyright
Ludwig Huber - LabCompliance
Slide 4
Example from EudraGMDP Website
Issue Date March 21 2014
Company and location
Nature of non-compliance : It was not possible to confirm the validity of stability testing data. Several falsified and inaccurate results had been reported in long term stability and batch testing. Discrepancies between electronic data and those results formally reported were
identified.
? Copyright
Ludwig Huber - LabCompliance
Slide 5
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