Professional Documents
Culture Documents
Results
1
QUALITY CONTROL FOR REGULATED
ENVIRONMENTS
UNIVERSITY OF HOUSTON
OOS
(Out of Specification)
2
CGMPs
3
21 CFR 211.192
Any unexplained discrepancy of the failure of a
CGMPs
4
21 CFR 211.192
The investigation shall extend to other batches of
Barr lost and the judge who heard the case, Judge Wolin, issued a ruling commonly
referred to as the Barr Decision
The Barr Decision made the OOS problem into a major problem for the QC
This creates additional work for QC laboratories, and an intense desire to simplify
investigations by blaming OOS results on laboratory error
This can create situations in which retesting leads to testing a product into compliance with
repeated claims of laboratory error
An outside observer might conclude that the laboratory is not competent to be performing the test.
Barr (contd)
7
Barr Decision
9
Immediate
Timely follow-up
Appropriate resolution
Documented
Avoid
Testing into Compliance
10
Linkage of Systems
11
EVENT
Identify All Lots
Consider All Possibilities
Investigation
Product Impact
Root Cause
Corrective Action
Preventive Action Lot Disposition
Purpose of Investigations
Identify
Correct
Evaluate Product Impact / Disposition
Prevent Similar Events from Happening in the Future;
Validated methods?
Changes in validated methods?
Qualified and calibrated laboratory equipment?
Correct instrumentation parameters?
Correct sample and standard weights?
Reference standards dried properly?
What
When
Where
What Immediate Actions Were Taken
Justify Selection
Remember Distributed Lots
OOS Investigations:
FDA Focus
18
results
Summary of specific investigation steps:
OOS Investigations:
FDA Focus (continued)
19
business days
Well documented
Scientifically sound
Tracked or Completed