USP <1224> - Transfer of Analytical Procedures

What it says

When an analytical procedure is transferred from one laboratory to another, such as from a development lab to a quality control lab or between manufacturing sites, the transfer should be managed through a documented, scientifically justified approach, using one of several recognized transfer strategies appropriate to the method's complexity and risk.

Paraphrased for plain-language clarity. Always verify against the current published regulation text.

What it means in practice

• A poorly managed method transfer is a common, underappreciated source of laboratory data integrity issues, since a receiving lab that cannot reliably reproduce a method's validated performance will generate results that look suspicious even when nothing is actually wrong with the product.
• This chapter recognizes that not every method transfer needs the same rigor, a simple, well-understood method may only need comparative testing, while a complex or high-risk method may warrant full revalidation at the receiving site.
• Method transfer documentation created under this chapter becomes part of the evidentiary basis connecting a receiving lab's results back to the original method validation performed under ICH Q2(R2).

What inspectors look for

• Whether a documented, risk-appropriate transfer protocol was followed and successfully completed before the receiving laboratory began using the method for routine release testing.
• Whether the transfer approach selected, comparative testing, co-validation or revalidation, matches the complexity and risk of the specific method being transferred.
• Whether any performance differences observed during transfer were investigated and resolved before the method was accepted for routine use.

Related regulations