Analytical method transfer

For any new excipients, APIs or drug products (where new does not necessarily mean novel, but new to the receiving site) there are additional testing criteria, e.g. supplier audits, third-party contract laboratory audits, analytical method transfers, sample management/tracking, etc. For those key excipients, where there is on-site historical experience, it still behoves both parties to check whether the local grade/supplier used by the CMO is equivalent to that used by the supplier (Worsham, 2010). There are many examples of differences in excipient physical properties, e.g. particle size, which have been attributed to different excipient sources that could ultimately impact on the performance of those excipients in formulated products (Frattini and Simioni, 1984 Dansereau and Peck, 1987 Phadke et al., 1994 Lin and Peck, 1994). 

Table 1. Pre-defined Analytical Method Transfer Acceptance Criteria for API and Drug Product (adapted from Agut et al., 2011)...

De Fontenay, G. Analytical method transfer New descriptive approach for acceptance criteria definition. J. Pharm. Biomed. Anal., 46, 2008, 104-112. 

Raska, C. S., Bennett, T. S., Goodberlet, S. A. Risk based analytical method transfer Application to large multi-product transfers. Anal. Chem., 82, 2010, 5932-5936. 

Scypinski, S., Roberts, D., Oates, M., Etse, J. Pharmaceutical research and manufacturers association acceptable anbalytical practice for analytical method transfer. Pharm.Technol., 28, 2004, 84-88.2004... 

The small vessel and minipaddle dissolution method described in Table 10.7 has been extensively used by the originating laboratory. In addition, the method was successfully transferred to several laboratories, demonstrating the method s reproducibility and ruggedness. The data for the analytical method transfer exercise (AMTE) to one of these laboratories is shown in Table 10.7. The AMTE used a bracketing... 

Since the aim of the protocol is to ensure the mitigation of problems, the essential elements of the protocol consists of sections that include (a) an Introduction, (b) treatment and disposition of data, (c) types of methods being transferred, (d) materials, reference standards, and reagents being used, (e) recommended type of equipment, (f) sample handling, (g) predetermined acceptance criteria, and (h) an Acknowledgment section. An example of a typical table of contents (TOC) of an analytical methods transfer protocol is discussed in Table 16-2. 

S. Scypinski, D. Roberts, M. Oates, and J. Etse, Pharmaceutical Research and Manufacturing Association acceptable analytical practice for analytical method transfer, Pharm. Technol. March (2002), 84—88. 

The transfer of analytical methods may be a component of the overall process of technology transfer involving transfer of several methods simultaneously, or it may be limited to transfer of an existing method to qualify an additional testing site (see Chapter 14). In simplest terms, the analytical method transfer is conducted to ensure the following ... 

Analytical method transfer should be performed using a validated procedure this transfer data can be useful in determining intermediate precision of the method. The transferring laboratory should ensure that the recipient laboratory(s) is (are) current Good Manufacturing Practice (cGMP) compliant a record of successful audit by QA personnel is essential, especially if the laboratory is a contractor. 

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... 

Scypinski S, Roberts D, Oates M, Else, J (March 2002) PhRMA acceptable analytical practice for analytical method transfer. Pharm Technol 26, pp 84-88... 

ISPE (2003) Good practice guide technology transfer, analytical methods pp 23-34 Swartz M, Krull 1 (November, 2006) Analytical method transfer. LCGC N Am vol 24 (11), pp 1204-1214... 

Reproducibility Reproducibility assesses the closeness of agreement between a series of measurements obtained by the analysis of the same samples by different laboratories and is often performed during analytical method transfer. Precision is analyzed separately for each laboratory. 

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... 

The timing of analytical method transfers to support commercialization of products in global markets should be identified by the regulatory liaison. The requirements for product registration vary by country. Some countries will accept... 

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. 

This chapter highlights the important aspects of the analytical transfer processes as they relate to process, compliance, analytical data, and documentation. Types of method transfers and the timeline of transfer activities are discussed. The risk assessment prior to initiation of transfer activities is also described. The chapter describes content and utility of the transfer protocol and final report, as well as documents that govern analytical method transfers (i.e., SOPs and master plan). The importance of selecting appropriate method transfer acceptance criteria and use of statistical methods to evaluate results are described. The significance of the inclusion of an adequate level of detail in the methods, protocol(s), and other documents cannot be overly stressed. Last of all, the process for transfer of technical ownership of the analytical methods is discussed. Other chapters in this text should be consulted for elaboration on the various important facets of technical transfer, including method development, method validation, documentation, and stability. 

Schepers, U. and Watzig, H. Application of the equivalence test according to a concept for analytical method transfers from the International Society for Pharmaceutical Engineering (ISPE). /. Pharm. Biomed. Anal. 39 310-314, 2005. 

Dewe, W., Govaerts, B., Boulanger, B., Rozet, E., Chiap, P. and Hubert, P. Using total error as decision criterion In analytical method transfer. Chemometr. Intell. Lab. Syst. 85 262-268, 2007. 

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