Biomedical Engineering Reference
In-Depth Information
SOP No. QCS-017.00 Effective date: mm/dd/yyyy
Approved by:
Subject: Analytical Methods Transfer for New Products
17.1 PurPose
The purpose of this procedure is to outline the process and requirements for transfer of validated
analytical methods from third-party laboratories to the other manufacturing site.
17.2 scoPe
This procedure must be followed for any transfer of validated chemical or physical or analytical
methods in support of a new product transfer. This will also apply for the transfer of new analytical
methods in support of an existing product.
17.3 resPonsibility
It is the responsibility of the QC analysts to follow the procedure. The QC manager is responsible
for SOP compliance.
17.4
definitions
1.
Chemical or physical analytical method:
Any analytical method that involves physical or
chemical measurements including but not limited to, chromatographic, titrimetric, and
spectrophotometric methods and excluding biological and microbiological methods of
analysis. Limit tests are not included.
2.
Transfer of validated chemical or physical analytical methods:
The transfer of a method
from the contract manufacturing laboratory to any other company's laboratories.
3.
Project leader:
The project leader is the person in the contract manufacturing laboratory
assigned to define which methods require transfer, and executes and monitors the method
transfer process.
4.
QC analyst:
The QC analyst is the person assigned at any one of the other company's
laboratories, in coordination with the project leader, to properly execute the experiment
involved in the method transfer, and prepare a report summarizing the results of the study.
5.
Project supervisors:
The project supervisor is the person assigned the overall responsibil-
ity for the proper and timely execution, and reporting of, as well as approval of the results
of the transfer.
17.5
Procedure
1. The project leader, in coordination with the QC manager, would review the Method and
Validation Report to arrive at a decision with justification for a recommendation for a for-
mal transfer of the method. Such recommendation should be approved by the analytical
manager or designate. The United States Pharmacopeia (USP) test methods will not require
a formal transfer. Also excluded are simple in-house developed test methods which have
characteristics similar to the existing QC test methods for which the QC laboratory has
demonstrated expertise.
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