QCS-018 - Quality Operations Procedures for Pharmaceutical, API, and Biotechnology - page 95

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

b. Whenever retesting is called for in this procedure, retesting must be conducted on the

original laboratory sample. A resample can be done where

i. Inappropriate sample has been identified as the assignable cause of unexpected

result.

ii. There is insufficient original laboratory sample to complete all the required testing.

iii. A process investigation is required.

c. If an error is detected during the course of any analysis, the analyst/technician
must not knowingly continue the testing. Where no result on any test sample has
been generated, the test run may be invalidated with documented rational (on the
laboratory notebook), and with supervisor/manager approval, the test may be
restarted.

18.5 resPonsibility

18.5.1 Qc a nalySt

1. It is the responsibility of all QC analysts to notify their supervisors of any nonconformity,
OOS, or suspect test results.

2. Reporting initial test results: (see Form 01)

a. The analyst must notify the responsible supervisor of an OOS result generated.

b. The analyst must retain all test samples, standard solutions, equipment and instru-

ments used for testing, and glassware, including pipettes and syringes, until the
obtained data has been analyzed. These may be used for further investigation.

Note: Investigation of test result failures is essential in confirming whether an OOS result can be
attributed to error or whether the result represents the actual condition of the material or process
being evaluated.

c. The analyst must start the OOS lab investigation report (see Form 01) by filling out the

header information, including product/material name, batch/lot number, analyst name,
and date.

d. The analyst must describe the unexpected result in the section provided and state the

test limits or acceptance criteria, the laboratory notebook, and page reference.

18.5.2 P reliminary l aB i nveStigation : (S ee f orm 01)

18.5.2.1

Qc analyst and supervisor

1. It is the responsibility of the QC supervisor to inform the QC laboratory manager and
perform preliminary investigation.

2. The analyst and lab supervisor must conduct a preliminary investigation to determine if
an assignable cause for the unexpected result exists. The investigation may include but is
not limited to any or all of the following areas.

18.5.2.1.1 Raw Data Review
• Was the calculation correct?
• Was the work done accurately?
• Comparison of results to certiicate of analysis (CoA), historical data, or trends.