QCS-018 - Quality Operations Procedures for Pharmaceutical, API, and Biotechnology - page 94

SOP No. QCS-018.00 Effective date: mm/dd/yyyy
Approved by:

18.1 PurPose
This SOP describes the procedure of reporting and investigating out-of-specification (OOS) or
atypical results. It applies to quantitative and qualitative tests generated in the QC laboratory. This
procedure also describes the process for retesting following the laboratory investigation into a labo-
ratory error.

18.2 scoPe
This procedure applies to all test results generated at the QC laboratory that do not conform to
specifications. This procedure is applicable to OOS investigation of raw material, in-process, bulk,
final container, and stability (including ongoing and accelerated studies) test results. The purpose of
the investigation is to determine that the results are correct and a laboratory error has not occurred.
As appropriate, the procedure may also be used in the investigation of suspect or out-of-trend
(OOT) test results that are within specification.

references

1. Investigating Out of Specification (OOS) Test Results for Pharmaceutical Production, FDA—CDER
Draft Guidance, 1998.

2. USA 21 CFR, Parts 210 and 211 “Current Good Manufacturing Practices.”

18.3 definitions
Assignable cause: An event supported by documented evidence, which has resulted in an
erroneous test value or an uncompleted set of data.
Control sample: Samples with known test value, such as a retain sample of previously released
batches.
Error: The difference between observation or calculated value and the true value due to varia-
tions in measurements, calculations, or observations of a quantity due to mistakes.
Unintentional deviation from a standard or specification.
Investigation: A systematic examination and inquiry of an incident, condition, or situation.
Out-of-specification (OOS): Any individual test value that does not conform to specification.
Out-of-trend (OOT): Any individual test value that is within specification but is scientifically
questionable or does not follow expected trends.
Resample: A new representative of the lot or batch obtained using the normal sampling pro-
cedure, or a sample collected from original containers and same portion.
Retest: A repeat of a test using the original laboratory sample.
Suspect test result: An unexpected test result based on historical analytical trends and/or cur-
rent material action limits.
Unexpected result: Any result that is out of specification or out of trend.

18.4 Procedure

1. General

a. If there is sufficient evidence, the product/material may be rejected at any time during

the OOS investigation (e.g., presence of foreign material in the sample or the material
is not homogeneous).