Dear Members:
I would be interested in hearing your experience and viewpoints on
handling of Out-Of- Specification situations.
1. Do you feel that the following situation meets with the intent of the
modified GMPs, May, 1996 with regards to OOS? Whenever an OOS result is
obtained, a lab. investigation is conducted. If an analytical error is
found, the result is invalidated and the test is repeated once only. If
the investigation is inconclusive, retesting may take place with a double
amount of the same sample by 2 analysts in order to confirm or discount
the initial result. Only if both double tests are well within
specifications and not close to the initial result, the unexplained OOS
is invalidated.
Does retesting in duplicate by each of 2 analysts consitute a
statisically sound rationale to determine the true value of a sample when
confirming an OOS lab result that does not have a clear determinant
error? Is this approach consistent with the GMP rewrite?
2. What is your position on the treatment of OOS results? Do you average
OOS and within specification analytical test data when the OOS result is
statistically significant with the within specifications?
Any additional insight into the matter is greatly appreciated.
Paulette Kosmoski
Oxford Research
email: kosmoski@mail.oric.com
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