Analytical method transfer guidelines from FDA

Theoretically speaking, analytical method transfer guidelines from FDA are quite simple. The logic behind analytical method transfer guidelines from FDA is like this: in its elementary form, analytical method transfer is the way by which a laboratory becomes qualified to use a test procedure.

In setting out analytical method transfer guidelines, FDA makes it mandatory and necessary for laboratories to be compliant when transferring analytical methods. The rationale for this entire process is that there should be compliance to set guidelines, which statistical and practical treatment of the resulting data will govern.

Validation is the key to transfer

At their root; analytical method transfer guidelines from FDA rest on the logic that strong transfer methods begin with validation. Whenever a methods transfer between two or more laboratories takes place; it is said to be completed successfully when the receiving laboratory obtains what is called“reportable data”.

Where did it begin?

At the annual workshop of the Pharmaceutical Research and Manufacturers of America (PhRMA)’s Analytical Research and Development Steering Committee (ARDSC) held in September 2000; the importance of analytical transfer was highlighted. Analytical method transfer guidelines from FDA were finessed at this meeting, when representatives from PhRMA member companies met with facilitators and drafted an Acceptable Analytical Practice (AAP) document. The aim of this AAP was to serve as the ideal first-step guidance document towards conducting successful method transfer activities.

Analytical method transfer guidelines from FDA are welded into the AAP, which aims to provide this required guidance and to also clarify the fundamentals that are needed for a total and compliant transfer.

Reference:

http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/112002/12532/article.pdf

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