Analytical validation technology transfer

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...

Key words Valid analytical measurements Marketing technology Technology transfer... 

It is extremely beneficial to have a comprehensive analytical development report that provides the scope of each analytical method, chronology, rationale for changes, and equivalency or superiority of the optimized methods. Usually, the analytical development report for each method, along with the validation report, facilitates the technology transfer process. 

Analytical methods validation and technology transfer reports for drug substance and drug product... 

The process for the transfer of analytical methodology is, on the surface, a relatively simple operation. In its most common form, analytical method transfer is the verification that a method or test procedure works in an equivalent fashion at two or more different sites or laboratories and meets all acceptance criteria. This process is driven by compliance and governed by a statistical treatment of the resulting data. This interlaboratory transfer aspect of the overall transfer process has been covered comprehensively by McGonigle, who stressed that successful transfers are linked to the method validation process. Method transfer was defined in this case as the introduction of a validated method into a designated laboratory so that it can be used in the same capacity for which it was originally developed. The second portion of the technology transfer... 

Compliauce—including GMP documents (e.g., validation reports, investigation reports, and annual product reviews), internal reports (e.g., technology transfer reports), and special development reports (summarizing history of product or chronology of critical issues). Research—usually prepared to record or transfer product history (e.g., analytical profiles), additional informational studies, non-GMP batch issues and investigations. 

Boudreau SP, McElvain JS, Martin LD, Dowling T, Fields SM (2004) Method validation by phase of development an acceptable analytical practice. Pharm Technol 28, pp 54-66 Sixsmith DG (2001) Outsourcing resources third-party technology transfer. Pharm Tech, pp 58-62... 

The complete four-component system is necessary when the diagnostic requirement is rapid, low unit-cost analysis for both the strain-level characterization of pathogenic agents and identification of hoax bio-terror materials. Using the complete system, we are proposing to validate MS-based microbial taxonomy and to transfer the technology from an analytical research to a clinical or public health production-diagnosis environment. 

It is important to include the receiving lab early in the development process of analytical methods. In this way, the receiving lab can provide critical input that may be primordial for a successful application in QC. In return, the receiving lab will be familiarized with the resulting method description and can receive proper training of analysts to perform the method, prior to final validation of the method. As a result method transfer activities are bound to be successful. This concept is essential for new technologies such as CE to be introduced in the QC environment. 

APV (1981) International Association for Pharmaceutical Technology Praxis der Validierung (Validation in Practice), Symposium (1981-1982, Gelsenkirchen) [6] Terminology, sterile, semisolid, and solid dosage forms in development and production, analytical methods and stability evaluation, packaging development and packaging validation transfer, cost-effectiveness... 

Another professional organization headquartered in central Europe, APV (International Association for Pharmaceutical Technology, Mainz, Germany), developed the topic further in two seminars in Gelsenkirchen in late 1981 and early 1982 [6]. Speakers from industry demonstrated how validation could be applied to industrial activities and how a balance between resources allocation and results could be achieved. Oral dosage forms, topicals, and sterile products, as well as analytical methods during development, transfer, and production phases were discussed. 

Besides the existence of validated HPLC methods, the availability of a finalized API synthetic scheme and optimized formulations is another prerequisite for ensuring a successful transfer of analytical technology from research and development to commercial operation (Figure 16-1). Evaluation of data generated from the HPLC analysis of the API provides the means by which determination is made about whether a validated API synthetic scheme exists and if the API can be made reproducibly during commercial operation. 

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