Transfer of Technical Ownership

At the heart of the technical transfer process is documentation. The old adage if it isn t written, it isn t done certainly applies to analytical transfer. The 

The analytical development report is a documented summary and logic flow of all essential analytical information acquired during the R D phase of the project. In many cases, this report serves a variety of purposes it is a repository of all important analytical information pertaining to the project and is therefore a source document for the quality unit, and it is also used in the preparation of the site inspection at the time of product approval. All information contained in this report must be traceable to raw data and other reports, if applicable. Table 3 contains a summary of all information that should be contained in the analytical development report. The format of the report is not critical, but the information must be present. For further details on the various sections and chapters in this report, the reader is referred to other chapters in this text that describe the details therein. 

TABLE 3 Suggested Content of the Analytical Development Report 

Overview of project Statement of analytical testing Pertinent background information on test article (summary of synthetic scheme for substance, composition/manufacturing process for dosage form) 

Summary Summary of drug chemistry of substance Discussion of potential impurities and degradation products Degradation mechanisms and relevance Preformulation data summary 

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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. 

It is a peculiar and remarkable aspect of academic journals that their publishers make a profit while receiving almost all their copy entirely for free. Almost all journals require transfer of copyright from authors to publisher upon acceptance of submitted manuscripts. Technically, this requires that an author needs specific permission from the publisher to use his own manuscript later in practice, this permission is routinely granted upon written application. A few journals now seek only exclusive licenses from authors, one condition of which preserves the author s right to personally use his own work, and which leaves copyright ownership with the author(s) the license can also become void if the publisher fails to exploit it, and can yield royalties to the authors. In practice, this license removes the administrative burden of granting routine permissions by the publisher, and royalties on journal reprints are either nominal or absent. 

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