19.11.2019 | LOGFILE Feature 43/2019

Transfer of analytical procedures to the contract laboratory

Transfer of analytical procedures to the contract laboratory

4 min. reading time | by Frank Böttcher

 

An excerpt from the e-book Managing Contract Manufacturers and Testing Labs and the online knowledge portal GMP Compliance Adviser

The transfer of the analytical procedure can occur in different ways. If a transfer is possible with the involvement of the contract acceptor, a sample can be divided and tested by both laboratories at the same time. The results can then be compared to see whether they differ from each other. In this way, information is gathered about the accuracy and precision of the procedure. This can be sufficient for assay methods which are carried out by titration, for example.

During chromatographical testing, additional information concerning linearity and specificity, for example, is required. Information concerning the limit of quantification and the limit of detection should be evaluated in some case (see GMP Compliance Adviser, Chapter 14.D Validation of analytical methods).

If a detailed system suitability test (SST) was established during development and validation of the procedure in which the separation capacity of the system is tested, a revalidation of the specificity of the method can be omitted in the contract laboratory. If, for example, the linearity of the procedure is determined with a multipoint calibration covering the range of the analytical method, a single-point calibration can be used afterwards.

The robustness of the procedure in general is usually not tested during the transfer of test methods. It can be helpful to carry out tests in both laboratories using different personnel to obtain data on laboratory precision.

In the event of a change in laboratory without the possibility of involving the previous laboratory, it must be decided on the basis of the available validation documents whether a new validation is necessary or a revalidation of individual parameters is sufficient. In the case of chromatographic procedures, values for the evaluation of specificity, linearity, accuracy and precision of the range as well as the detection and determination limits for impurities should be generated during the test. This data must then be compared with the initial validation of the procedure in order to evaluate whether the procedure in the contract laboratory is valid.

Since the tasks to be carried out depend on the quality of the existing documentation, the method itself and previous experience, the transfer should be planned and carried out on the basis of a suitable risk evaluation.


Figure 1 Content of a plan for analytical transfer of methods

 
Frank Böttcher

Author

Frank Böttcher, PhD
Managing Director and Qualified Person at HWI pharma services GmbH
E-Mail: f.boettcher@hwi-group.de
 
GMP Focus

GMP Focus


An excerpt from the e-book Managing Contract Manufacturers and Testing Labs and the online knowledge portal GMP Compliance Adviser

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This e-book is an excerpt from the GMP Compliance Adviser.


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