Quality control method transfer

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... 

Snow, especially its water-soluble fraction, is one of the most sensitive and informative indicators of mass-transfer in the chain air - soil - drinking water. Therefore analytical data on snow-melt samples were selected for inter-laboratory quality control. Inter-laboratory verification of analytical results estimated in all the groups have shown that relative standard errors for the concentrations of all the determined elements do not exceed (5-15)% in the concentration range 0.01 - 10000 microg/1, which is consistent with the metrological characteristics of the methods employed. All analytical data collected by different groups of analysts were tested for reliability and... 

Eollowing finalization of drug substance synthetic routes and drug product formulation, the focus shifts to the development of robust and transferable methods for post-approval support at quality control units. It is important to remember during the final stage of method development that achievement of separation conditions is only one of the necessary parameters for successful method implementation. Extensive studies to measure robustness and quantitative method performance are conducted to assure that the method performs as intended in quality control laboratories. It should be emphasized that successful method development requires extensive cooperation between the development laboratory and the receiving quality control laboratories. 

Final methods are developed for transfer to operational quality control (QC) laboratories for the release testing of production batches. Additionally, the methods are intended to be applied during Registration Stability studies and for the release of the DP or DS validation batches during the pre-approval development stage. The analytical methods should last for the entire product lifetime therefore, the aim of final method development is to generate fast, robust, reliable, and transferable HPLC methods (preferably isocratic and at low cost). 

The environment in which a method is used changes significantly when the method is transferred to a quality control laboratory at the manufacturing site. The method may be replicated in several laboratories, multiple analysts may use it, and the method may be one of many methods used in the laboratory daily. The developing laboratory must therefore be aware of the needs of the receiving... 

Analytical potency method development should be performed to the extent that it is sufficient for its intended purpose. It is important to understand and know the molecular structure of the analyte during the method development process, as this will facilitate the identification of potential degradation impurities. For example, an impurity of M + 16 in the mass spectrum of a sample may indicate the probability of a nitrogen oxide formation. Upon successful completion of method development, the potency method will then be validated to show proof that it is suitable for its intended purpose. Finally, the method validated will be transferred to the quality control laboratory in preparation for the launch of the drug substance or drug product. 

The responsibilities for suitable validated analytical methods, however, do not rest solely in the analytical method development group. Today the analytical function uses new and sophisticated chromatographic and other instrumental techniques that require a high level of technical expertise. It is the responsibility of quality control management to ensure that its staff is adequately trained and its laboratories properly equipped so that new analytical methods can be properly transferred from an analytical methods group to the quality control department. A mutual understanding of each other s responsibilities and limitations is... 

Similar to the methods validation protocol, it is recommended to obtain approval signatures from both the director of quality control and quality assurance because of the regulatory criticality of a method transfer exercise. 

Quality control, pharmaceutical product identity checks, and quantification are important fields in the broad application of the different spectroscopic methods. There are many spectroscopic aspects, e.g., concerning sample preparation, influences from different accessories, and possibly spectrometer effects, which certainly influences quantitative measurements. The latter problems could be solved using calibration transfer between different spectrometer types, for example, a scanning and an FT-near-IR spectrometer. 

The control of these physical characteristics is performed through the development, validation of a suitable analytical method and setting up of relevant specifications followed by method transfer to industrial quality control laboratories. 

---