Learn Documentation in technology transfer in pharmaceutical industry Documentation contains Development Report, Plan and Reports.
What is Documentation in Technology Transfer?
Documentation in technology transfer refers to the process of capturing and recording essential information, procedures and knowledge related to transferring a technology from one organization to another. Each and every step performed from R&D to production, task assignments and responsibilities should be documented carefully. The quality assurance department is responsible for examining and approving the documents related to technology transfer processes. The reports involved are:
- Development Report
- Technology Transfer Plan
- Reports.
Development Report
The development report is a crucial document for successful technology transfer in the pharmaceutical industry. R&D department will prepare this report and will serves as evidence of the research and development activities. The report includes the following information:
- Data on the development of new drug substances.
- Drugs produced at various stages from development to final approval.
- Details of raw materials and components used in the drug development process.
- Reasons for different dosage forms, formula designs, and manufacturing methods.
- Changes made to existing processes and control parameters.
- vi) Information on the stability profile of the drug.
- Specifications and test methods for drug substances, intermediates, and raw materials, including important tests like contents, impurities, and dissolution.
- Explanation for the selection of test methods, reagents, and columns.
- Traceability of raw data.
These details provide a comprehensive understanding of the drug development process and ensure the quality design of the drug substances. The report serves as a reference for approval and also provides valuable data for post-marketing technology transfer.
Technology Transfer Plan
The Technology Transfer Plan serves as a guide for the transfer process, outlining the necessary steps and criteria for successful technology transfer. Here is a simplified list format highlighting its key aspects:
- Defines the items and contents of the technology to be transferred.
- Outlines the transfer procedures and schedules.
- Establishes criteria for judging completion of the transfer.
- Organized by the transferring party.
- Requires agreement with the receiving party on the plan’s contents.
Report
After the completion of technology transfer, make a report is by selecting data as per the technology plan and ensuring whether or not the predetermined judgement criteria. The technology transfer report can be documented by both transferring and transferred parties who should reach an agreement regarding its contents.