QCS-017 - Quality Operations Procedures for Pharmaceutical, API, and Biotechnology - page 89

SOP No. QCS-017.00 Effective date: mm/dd/yyyy
Approved by:
2. The project leader, project supervisors, and QC analysts must schedule a method transfer
review meeting prior to initiation of the formal transfer study. At this meeting a review of
the method development and validation and test method SOP should be conducted. Where
necessary, a trial run should be performed to verify proper operation of equipment and
understanding of the test method SOP prior to initiation of the study. The project leader
from contract manufacturing laboratory will remain actively involved to resolve any issues
related to the execution of the test method SOP.
3. A representative sample will be obtained by the project leader and provided to the QC
analyst. The project leader should ensure that proper identification/documentation of the
sample is received by the QC analyst before the experiment is performed. The QC analyst
must also ensure that the proper documentation is received.
4. Other necessary materials, such as the validation report, a clear and thorough SOP, refer-
ence standard, reagent-type information, and so on must also be documented and fur-
nished by the project leader to the QC analyst.
5. For those methods which require a formal transfer study, a precision run (repeatability)
will be performed at the plant QC laboratory. Six independent test preparations from a
homogenous sample will be performed per the approved test method SOP.
6. Results will be reviewed, and approved if acceptable, by the QC manager.
7. The QC manager will prepare a concise report. Review and approval will be obtained from
the project supervisors at each site.
8. If the acceptance criteria are not met, an investigation will be conducted. If the source of
the error is identified, corrective action is implemented and the precision run is repeated.
If the source of error is not identified, two more precision runs are performed for further
evaluation. If a conclusion still cannot be arrived at, an investigation and course of action
will be developed and documented.
17.6 accePtance criteria
1. System suitability limits must be met.
2. The % RSD of the six preparations meet the repeatability criterion established in
the Method Validation Report and the average of the six results meet the regulatory
specifications.
3. For chromatographic methods, chromatograms are comparable to those obtained in the
Method Validation Report.
17.7 documentation
Each step in the method transfer report will be documented. Documentation required in the SOP or
monograph being tested and any internal SOP on documentation will be followed.
The results of the transfer study will be documented on the attached report form (Attachment I).
17.8 reason for revision
First time issued for your company, affiliates, and contract manufacturers.