Technology transfer analytical

A critical activity that precedes the start of analytical technology transfer is to assess whether suitable instrumentation and qualified personnel are available at the receiving laboratory. The receiving laboratory is the laboratory to which the analytical methods are transferred to. This assessment is accomplished through the organization of an analytical challenge meeting. The purpose of... 

The transfer of analytical methodology allows for a successful transfer of technology development for a new drug product. As mentioned previously, it is a very important document, even though on the surface it may appear to be a relatively simple operation (Chapter 14). The important elements of analytical technology transfer are the following ... 

Technology transfer may involve the transfer of an analytical method from a research group to an analytical group, the transfer of a method from one analytical laboratory to another analytical laboratory or to a quality control... 

A firm understanding of the chromatographic system is expected of the analyst who developed an analytical procedure. However, when this procedure is transferred to another analyst, problems may occur. The problems may stem from differences in the chromatographic system, column variance, temperature fluctuations, mobile phase variability, and other factors. The standard means to ensure that the procedure transfers (technology transfer) successfully is through the use of system suitability... 

R. P. Cogdill, C.A. Anderson and J.K. Drennen III., Process analytical technology case study. Part III calibration monitoring and transfer, AAPS PharmSciTech., 6(2) E284—E297 (2005). 

A pilot production is at about a lOOx level in general, the full scale-batch and the technology transfer at this stage should comprise preformulation information, product development report, and product stability and analytical methods reports. This is the time to finalize the batch production documentation for the lOOx level. The objectives of prevalidation trials at this stage are to qualify and optimize the process in full-scale production equipment and facilities. 

When the method development process has been completed, an analytical procedure is subject to validation and transfer to routine use. This process may be called technology transfer which implies migration from the R D environment to routine analytical laboratories. This process needs to be carried out whether the applicability of the procedure is limited to a single laboratory or to many laboratories. 

Table 20 Technology transfer validation requirements for published analytical methods...

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