Method Transfer - USP Plans New General Chapter

In the Pharmacopeial Forum of September / October 2009, a "stimuli article" was published that is meant to become the basis for a new general chapter in the American pharmacopoeia (USP) on the transfer of analytical test procedures. The USP already includes several general chapters on the procedure for data collection, e. g. in the qualification of analytical equipment, analytical method validation and the verification of pharmacopoeial methods. The new general chapter that has now been proposed in this article is meant to continue this series.

It is the aim of a method transfer to qualify the laboratory that will carry out an analysis in the future for independently and successfully conducting an analytical procedure that has hitherto been performed at another laboratory and for receiving the knowledge and skills necessary for this.

The article in the Pharmacopeial Forum intends to initiate a discussion on this topic and to gather comments from all stakeholders.

This article classifies different types of transfers and shows what a transfer protocol can look like. Statistical methods are not included in this article, and it is also pointed out that this chapter does not apply to microbiological or to biological methods.

The topics of this article are as follows:

  • Different types of transfers of analytical procedures
  • Comparative test
  • Co-validation between two or more laboratories
  • Methods verification or revalidation
  • Transfer waiver (transfer without the generation of comparative data)
  • Elements recommended for the transfer of analytical methods
  • Approved transfer protocol
  • The analytical procedure
  • Method transfer report

In case the acceptance criteria are not fulfilled in a method transfer, no formal OOS investigation is required; however, here, too, a thorough investigation has to be conducted and documented. After the method transfer has been completed successfully, the transfer report is created, which confirms that the new laboratory is now qualified to perform the analytical procedure.

If the acceptance criteria are not met, the method cannot be transferred. In this case corrective action must be taken until the acceptance criteria are fulfilled.

Günter Brendelberger
On behalf of the European Compliance Academy (ECA)

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