Chemistry Reference
In-Depth Information
Appendix: Example Method
Validation Protocol
The following is an example method validation protocol template that might be used
to validate a method internally, or in concert with an outsourcing laboratory. A docu-
ment of this type would typically include a table of contents; a detailed listing of all
the testing to be performed; the actual methods used (either as a part of the proto-
col or as an attachment); specific instructions on sample and standard preparations;
concentrations, numbers of samples, numbers of injections and the sequence; how to
treat the data; etc. The document should also include preestablished specifications.
Formats can vary: sometimes acceptance criteria are listed along with the method
attributes, or separately as presented here. Regardless of the format, the protocol
should be a numbered and controlled document.
Title:
Validation of Test Method No. XXXX (Method Title)
Study Sponsor:
Company Name and Address
Study Monitor:
Name, Title, and Contact Information
Test Facility:
Company Name and Address
Study Director:
Name, Title, and Contact Information
Study Number:
Proposed Experimental
Date:
Initiation and Termination Dates
Authors/Approvals, etc. Signatures:
Study Monitor
Name, Title, Affiliation
Study Director
Name, Title, Affiliation
Quality Control/Assurance
Name, Title, Affiliation
191
