Technology transfer documentation

The pilot-production program is generally a result of cooperation between the development laboratories and the manufacturing department. Technology transfer documentation applies to processes as well as to the systems being qualified and validated and their testing standards and testing methods. This documentation is important, particularly where an NDA is involved. 

Evaluate proposed changes against development and technology transfer documents ... 

Most tolls involve the transfer of proprietary information from one party to the other, typically from the client company to the toller. Each party should have maintained a log of transferred documents or software code to make the return of proprietary documents a simple matter. An initial list of the documents should have been referenced in the contract or as part of the technology package. Keeping records of additional documents transferred during the course of the toll will help eliminate confusion at the end of the project. The toller may need to retain documents appropriate for their process safety system needs. 

NIOSH. 1992. NIOSH recommendations for occupational safety and health. Compendium of policy documents and Statements. US Department of Health and Human Services, Public Health Services, Centers for disease Control, National Institute for Occupational Safety and Health, Division of Standards Development and Technology Transfer, Cincinnati, OH January 1992. 

A pilot production is at about a lOOx level in general, the full scale-batch and the technology transfer at this stage should comprise preformulation information, product development report, and product stability and analytical methods reports. This is the time to finalize the batch production documentation for the lOOx level. The objectives of prevalidation trials at this stage are to qualify and optimize the process in full-scale production equipment and facilities. 

Earlier I discussed a method of planning for PV, in particular the overall development function leading up to it. It appears that the development group has a number of avenues that will lead to the appropriate validation approach it takes. In one approach, the critical process parameters would be measured to monitor the process and document the fact that the process is validated. Many validation programs use this approach, but they are usually undertaken right after or as part of the technology transfer effort. 

Furthermore, ISPE is in the process of establishing guidance on process transfer. This is the result of a collaboration with the U.S. FDA and the American Association of Pharmaceutical Scientists (AAPS), with input from European regulatory authorities and the Japanese MHLW. This technology transfer guide is designed to present a standardized process and recommends a minimum base of documentation in support of the transfer request. 

In relationship to new product development, R D has a key role in the formation of the batch record. Without proper documentation maintenance at an early state of development, transferring the process from development to operations will be problematic at best. Development personnel should be cognizant of all the information needed by production operators responsible for scale-up and/or technology transfer. Consider the following ... 

As part of the preparation for creating the CMC document, the chemical development organization (or the manufacturing organization if technology transfer has already occurred) usually produces a minimum of three large-scale batches of the subject API using the procedure to be filed in the CMC documents. The results of this three-batch exercise demonstrate that the process operation and API quality are consistent with the criteria established for the CMC document. 

Technology transfer plans and reports are used by a research and development organization in order to document their official transfer of a newly developed or recently upgraded product/process from the developmental area and facilities to an operations unit and site, usually located in separate buildings, or at an entirely separate and different manufacturing sites. While the format and content has not been formally prescribed by FDA, companies generally include the following information in these documents ... 

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