Analytical Method Transfers: Effective Communication of Information is Crucial

By Wayland Rushing, Ph.D.

Senior Scientific Advisor

ABC Laboratories

www.abclabs.com

Analytical method transfers are a very common occurrence in our industry.  The range from simple to complex in nature and can be a source of regulatory headaches resulting in 483’s.  As a result it is still surprising the number of times the procedure is approached almost as an afterthought or check-box exercises without the proper thought and planning put into them.  One of the most common issues which I have observed is a failure to communicate critical information.  During the initial steps it is the originating lab’s responsibility to gather and effectively communicate the appropriate information the receiving lab will need to successfully complete the transfer.  This includes not only the analytical method but also may include QC, validation reports, internal SOPs and any other critical information required for the performance of the method.

The following are just a few of the comments encountered during failure investigations performed on method transfers which demonstrate the importance of effective communication between sites during the performance of a method transfer.

“Those specific instrument settings are set by SOP, so we didn’t list them in the method, did you need them?”

“Our internal SOP allows for variance of the method conditions as long as system suitability is met”

“The chromatograms in the method really are not representative of what we commonly see, attached are more common examples”

In each of the above instances, the originating lab failed to communicate critical information in the transfer package to the receiving lab. As a result, the method transfers failed during the initial executions resulting in delays and increased expense.

Prior to initiating the transfer here are just some procedures/questions that could be used to ensure the proper information is communicated:

·      • Get feedback from the lab personal who normally run the method

·      • Is the representative data being communicated really representative?

·      • Is there any information critical to the method contained in other documents, i.e. SOP’s?

·      • What are the common issues encountered internally with the method?

·      • Gather the make/model of instruments used on the method.

·      • Gather the validation report, any other transfer reports or addendums which have been

         performed

By not properly preparing and communicating you can inadvertently doom the transfer to failure ever before it gets into the lab.