Analytical Method Transfer Questions

All answers are relative to CONFIDENCE not risk

F-1 Has there been a product Very Low No site visit. 1
People related technical site Low Site visit with no analytical evaluation 3
visit? Moderate Completed site visit with observation(s) and action 7
Relationship plan
High Completed site visit with no observations 9

F-1 Are analysts in receiving Very Low Method techniques not in use 1
People lab experienced in
specific analytical Low One or more techniques not routinely in use in lab 3
Experience methodology? with 1 – 2 people experienced in method technique
and training required
Moderate At least one technique routinely used with ≤ 3 7
trained individuals and no training required

High Method techniques routinely used by > 3 people in 9

Receiving Lab.

F-2 Are all consumables Very Low Critical materials require qualification. 1
Lab specified in the method Low Non-critical materials require qualification 3
Infrastructure available through local Moderate Like for like replacement available. 7
supply chain? High Same vendors and grades. 9
Materials

F-2 What type of analytical Very Low No experience at the receiving site with required 1
Lab testing equipment is equipment
Infrastructure available at the receiving Low Equipment differences are significant enough to 3
site, compared to that of require method modification.
Equipment the existing site? Moderate Equipment is of similar design, different vendor 7
(Waters Alliance, HP1100) evaluation required.
High Identical equipment, vendor, model. 9

F-2 Has there been Very Low <80% No Analysis 1

Lab equipment evaluation for Low 80 – 100 Available capacity is 80 – 100%. 3
Infrastructure projected volumes? Moderate >100% Available capacity. 7
High >150% Far exceeds capacity need. 9
Equipment

F-2 Has there been FTE Very Low No analysis, <50% capacity. 1
Lab evaluation for projected Low Analysis gap, 50 – 75% capacity, no plan for new 3
Infrastructure volumes? hires.
Moderate Analysis gap, 50 – 75% capacity, approved plan to 7
Capacity increase staff.
High Full analysis of lab capabilities, >100% capacity. 9

F-2 Is the receiving lab Very Low Temperature and humidity effects not well 1
Lab environmental controls understood or controlled.
Infrastructure and its effect on the Low There are known variation outside method 3
method understood? operating ranges that will require method changes.
Controls Moderate Known variation within method operating ranges of 7
the method.
High Temperature and humidity controls well 9
understood and same as controlling lab.
F-2 What degree of solvent Very Low Critical solvents not allowed and require significant 1
Lab environmental method changes.
Infrastructure requirements impact the
method
Solvent
Low Non-critical solvent changes will impact the 3
validation status of the method.
Moderate Non-critical solvent requirements not expected to 7
impact validation status.
High No impact to the method. 9

F-3 Method What is the level of Very Low Highly complex method (e.g., for multi-active, 1
familiarity with the special sample prep) that represents a new
Analytical Test Methods technique for receiving site.
for Product Release and Low Complex method, new application of existing 3
Raw Materials? technology at receiving site. Method at or near
limits of instrument capability and requiring
significant scientific interpretation.
Moderate New method to Receiving Lab. Well characterized 7
method through data from Controlling lab. (e.g.,
R&D or other site).
High Well characterized, method (e.g., single active and 9
simple) and technology, within core competencies
and similar to current methods at receiving lab.

F-3 Method What types of changes to Very Low Extensive changes to multiple Test Methods from 1
Test Methods from the the Controlling Lab must be made (e.g., methods
Controlling lab to the not stability-indicating, not sufficiently reliable or
Receiving lab are accurate).
necessary?

Low Extensive changes to one Test Method from the 3

Controlling Lab must be made (e.g., method not
stability-indicating, not sufficiently reliable or
accurate).
Moderate Minor Changes to Test Methods from the Sending 7
Site must be made (e.g., slight changes to sample
prep, use of equivalent instrumentation).
High Little to no Changes to Test methods from the 9
Sending Site are required.

F3 Have critical materials Very Low At least 1 critical material have only one single 1
Method (eg HPLC columns or source
reagents) been qualified Low Alternative vendors qualified but require method 3
Materials with multiple vendors and modification
lots? Moderate Qualified alternatives but from the same vendors 7
High All critical materials have alternative vendors 9
qualified vendors and lots
F-4 Has the method as Very Low R&D only method 1
Method written been transferred Low Local QC with modification pending 3
Complexity outside of R&D Moderate In use in local QC currently as is 7
controlling lab? High Method in use at local Q and at least one 9
Nuances additional receiving lab

F-4 Method Has comparative analysis Very Low No analysis completed 1

Complexity of procedures been Low Analysis complete, differences presented to the 3
completed? manager
SOPs Moderate Similar procedures after completion of analysis 7
High Analysis complete, aligned procedures or receiving 9
lab follows controlling laboratory procedures

F-4 Method Have Receiving Lab Very Low No documentation review 1

Complexity bench analysts evaluated Low Bench evaluation not complete, documents 3
the method reviewed
Training experimentally? Moderate Lab experiments fully evaluated and completed 7
independently by receiving lab.
High Experimental evaluation of method completed in 9
the presence of Controlling Laboratory personnel

F-4 Method Does the method output Very Low New technique to lab that requires significant data 1
Complexity (data) required significant interpretation to accurately represents true results.
scientific interpretation? OR Method demonstrated requirement for
Data significant interpretation by analyst experienced
with method
Low Require some scientific interpretation that some 3
core competency in the receiving lab.
Moderate Method requires some scientific interpretation, 7
which is within the core competency of receiving
lab.
High Simple routine data output within competency of 9
the receiving lab.
F-5 Method What is the level of Very Low Significant number of laboratory investigations at 1
Performance analytical laboratory current site: > x% of batches tested, greater than
investigations associated laboratory norm by a significant degree
Robustness with the product/methods
at the current site?

Low Moderate: > x% of batches tested, greater than 3

laboratory norm, but not by a significant degree..
Moderate Minimal: < x% of batches tested 7
High None: < x% of batches tested 9