Method transfer report

The designated laboratory is responsible for issuing and following SOPs that define their criteria for accepting an analytical method. The method transfer report includes data generated in accordance with those SOPs. 

Once the protocol testing is complete, the result forms are provided to the protocol leader, typically from Lab A. The results from each lab are evaluated and if the acceptance criteria are met the work is summarized in a method transfer report. If there are results which do not meet the acceptance criteria, the transfer team meets to review the situation and determine the next steps. Other tests would be similarly documented a protocol for a degradation product transfer would include many of the same points as described above for the assay with the following additional points ... 

The old adage if it isn t written, it isn t done certainly applies to analytical transfer. The expectation of the health authorities is that a final report will be issued documenting the analytical method transfer process and associated results. Two types of records are subject to PAI Primary records that demonstrate safety, purity, and efficacy of the drug (e.g., batch records, test data) and supporting documentation such as equipment verification records, change control and development and validation reports that demonstrate the cGMP compliance status of the facility. The method transfer report is categorized vmder the latter set of documentation. 

Method Transfer. Method transfer involves the implementation of a method developed at another laboratory. Typically the method is prepared in an analytical R D department and then transferred to quahty control at the plant. Method transfer demonstrates that the test method, as mn at the plant, provides results equivalent to that reported in R D. A vaUdated method containing documentation eases the transfer process by providing the recipient lab with detailed method instmctions, accuracy and precision, limits of detection, quantitation, and linearity. 

Research reports—Research reports such as stability reports, method validation and transfer reports, and pharmaceutical development reports are key documents used for NDA/MAA filings. These documents are strictly version controlled. 

The lithium transference number (l,) of these organoboron polymer electrolytes was evaluated by combination of dc polarization and ac impedance methods, as reported by Evans et al44 (Table 1). The observed t+ at 30°C was 0.50-0.35, indicating that anions were significantly trapped in these systems. Owing to the stronger Lewis acidity of the alkylborane unit, alkylborane-type polymers showed relatively higher t+. 

In 1995, a new class of controlled/ living radical polymerization methods was reported by the groups of Matyjaszewski [34] and Sawamoto [35], This new process, named atom transfer radical polymerization (ATRP) [34], has had a tremendous... 

Reproducibility represents the precision of the method between two or more laboratories and it is typically assessed during method transfer between laboratories, but may be assessed during method validation when more than one laboratory will be performing the method. Reproducibility would also be reported as the SD or RSD value of the mean results between laboratories. These data are not part of the marketing authorization application. 

The present procedure Is a modification of the method previously reported. While the overall yield is similar, the method described here is simpler in that it avoids a cumbersome transfer of the sodium cyclopentadienide solution. 

Eventually the point will be reached at which the development of a product is complete the formulation is finalized, the equipment has been selected, the analytical methods are validated, the development transfer report has been issued, and the Preapproval Inspection (PAI) is anticipated. Now is the time to consider validation of both the manufacturing and cleaning processes. Although some process validation may have also been completed or a process validation protocol may have been prepared and approved, it is likely that very little has been finished that would enable us to state that the cleaning process is fully validated. 

Verifying that manufacturing equipment and product formulation are finalized (e.g., as specified in a development transfer report)—This is necessary since cleaning methods are product- and formulation-specific and will change if the formulation or equipment is changed. 

A common industry practice is to list the actual equipment used during the original validation in the validation report and analytical method. Quite frequently or equivalent will follow the listing. Since certain instrumental parameters can differ between manufacturers of basically the same equipment (e.g., UVdetectors for HPLC), it is essential to include experiments in the method-transfer exercise that are specifically designed to qualify the equipment as equivalent or suitable. 

Formal documentation of the method-transfer results as addenda to the original validation report would further substantiate the overall validation process. Thus, each new laboratory setting would either confirm the original method validation, or indicate a possible need for method modification with revalidation. 

The validation report should be a living document that reflects the dynamic validation process. Therefore, it should be updated using addenda to report method transfer results, ongoing system suitability and any revalidation efforts. 

Procedure or forms for investigating, reporting, corrective action New or revised methods Allowable circumstances Contract labs Method transfers Audits... 

In cases where a general QL is required, as in pharmaceutical analysis, it is essential to define a realistic QL (or DL) for the analytical procedure, independently from the equipment used, because this limit has important consequences (e.g., for the consistent reporting of impurities or for method transfer). They may be derived by taking QL (or DL) from various instruments into account ( intermediate QL, during the development process) or can be defined taking the requirements of the control test (specification limits imposed by toxicology or by a qualified impurity profile) into consideration. For example, a QL which... 

The on-line coupling between TLC and mass spectrometry provides a powerful combination for the detection and identification of substances separated by a planar chromatographic method. The on-line coupling between these two methods has to overcome the problem of vaporizing and introducing the sample into the mass spectrometer. Different methods are reported in the literature, but the analytical principle is the same the sample is ionized from the layer surface by means of a laser beam, under vacuum, and in the presence of an energy-buffering matrix. Once the ions are transferred into the mass spectrometer, more sophisticated methods can be applied for data analysis and interpretation, e.g., MS-MS. 

However, the (undisclosed) proprietary immobilization process appears to modify the enantiomer separation characteristics as compared to the coated versions [145, 146]. Ghanem et al. compared the chiral recognition profile of a coated CHIRALPAK AD CSPs with that of the immobilized version, employing hexane/ 2-propanol containing TEA (0.1%) as mobile phase [145]. They reported superior enantiomer separation for the coated CSP, with some analytes failing to resolve on the immobilized version. These differences in the enantiomer separation capacity of coated and immobilized polysaccharide-type CSPs may complicate attempts at direct method transfer. 

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

Once the method transfer experimentation is complete, the data are compiled and analyzed, and the final report drafted. The transfer report should indicate whether the transfer was successful and all data recorded and reviewed. The report should indicate the file or location of the raw data. Any deviations to the protocol should be appended to the report. 

---