Technology Transfer Toolkit

The analytical method summary serves to provide the most up-to-date information on all methods used for in-process testing, lot release, characterization, raw material testing, and other methods related to a specific process requiring transfer.

Download contains:

• Analytical Method Summary Template (.pdf, 3 pages)
• Editable Analytical Method Summary Template (.docx, 3 pages)

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A bill of materials serves to provide the most complete information on all components, raw materials, consumables, reagents, and biological materials.

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• Bill of Materials Template (.pdf, 3 pages)
• Editable Bill of Materials Template (.docx, 3 pages)

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The biological material transfer log serves to document the transfer of cells and intermediates in various stages of processing, including purified product and reference standard. The document provides basic information on the origin, nature, and key biological and safety properties of the materials in question.

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• Biological Transfer Material Log Template (.pdf, 3 pages)
• Editable Biological Transfer Material Log Template (.docx, 3 pages)

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The equipment list provides the most complete information on all critical and auxiliary systems for the manufacturing process and associated testing.

Download contains:

• Equipment List Template (.pdf, 3 pages)
• Editable Equipment List Template (.docx, 3 pages)

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The process characterization matrix serves to provide a summary of process parameters and their classification (i.e., their criticality). It allows for better understanding of the process and is useful when designing control strategies.

Download contains:

• Process Characterization Matrix Template (.pdf, 3 pages)
• Editable Process Characterization Matrix Template (.docx, 3 pages)

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A sampling plan serves to provide information on quantity, size, and nature of samples to be collected at various stages or unit operations for process control, release, or information purposes. It allows for better planning of materials, use of analytical equipment, and scheduling of process and laboratory operations.

Download contains:

• Sampling Plan Template (.pdf, 3 pages)
• Editable Sampling Plan Template (.docx, 3 pages)

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The solution formulation record outlines the minimum requirements for the successful transfer of information necessary for the preparation of buffers, media, and other solutions.

Download contains:

• Solution Formulation Template (.pdf, 3 pages)
• Editable Solution Formulation Template (.docx, 3 pages)

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This product is a template for writing Detailed Product and Process Descriptions (DPPD’s).  The DPPD serves to convey both the history and the most-up-to-date information on process steps, methods, equipment, and materials. It also conveys specifications for raw materials, components, intermediates, bulk drug substance and drug product whenever applicable.

Note: DPPD’s are also referred to as Technology Transfer Packages in some cases.

Download contains:

• DPPD Template (.pdf, 15 pages)
• Editable DPPD Template (.docx, 15 pages)

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This document gives instructions for writing Technology Transfer Master Plans. The Technology Transfer Master Plan is a key technology transfer document. It gives a high-level overview of the purpose and scope of the transfer, as well as outlines the project management strategy and specific technology transfer strategies, such as which prerequisites must be met before completing each phase of the transfer.

Download contains:

• Master Plan Template (.pdf, 15 pages)
• Editable Master Plan Template (.docx, 15 pages)

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The experiment protocol outlines the planning and execution of experiments, tests, and runs that should follow the completion of a process transfer from Sender to Receiver site. Examples of tables, diagrams, and charts have been added where suitable to provide further guidance on how to complete each relevant section.

Download contains:

• Experiment Protocol (.pdf, 15 pages)
• Editable Experiment Protocol (.docx, 15 pages)

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The experiment summary report serves to document details of an experiment performed, typically for a process transfer. The report gives rationale for the experiment and explains the materials, equipment, and procedures used as well as the results and conclusions drawn from the experiment.

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• Experiment Report Template (.pdf, 6 pages)
• Editable Experiment Report Template (.docx, 6 pages)

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The method transfer plan is an essential technology transfer document. It identifies all analytical methods requiring transfer to the Receiver site and the level of qualification or validation necessary for each method.

Download contains:

• Method Transfer Plan Template (.pdf, 10 pages)
• Editable Method Transfer Plan Template (.docx, 10 pages)

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The method transfer report provides documented proof that transferred methods perform at the Receiver's facility and in the Receiver's hands acceptably and comparably with the Sender.  This document also summarizes the results of executed qualification protocols for each individual method being transferred. Examples of tables have been added (where suitable) to provide further guidance on how to complete each relevant section.

Download contains:

• Method Transfer Report Template (.pdf, 3 pages)
• Editable Method Transfer Report Template (.docx, 3 pages)

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The process transfer plan details the strategies, activities, and timeline for transferring a process between different facilities, as well as to provide expected results and specifications.

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• Process Transfer Plan Template (.pdf, 12 pages)
• Editable Process Transfer Plan Template (.docx, 12 pages)

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The process transfer report provides documented proof that a process has been successfully transferred between Sender and Receiving sites. It also documents proof that the process performs at the Receiver facility acceptably and comparably with the Sender site and in accordance with the given acceptance criteria.

Download contains:

• Process Transfer Report Template (.pdf, 5 pages)
• Editable Process Transfer Report Template (docx, 5 pages)

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The risk assessment template provides a spreadsheet entitled "Technology Transfer Project Risk Register" to help organize and catalog risks with the program.

Download contains:

• Risk Assessment Template (.pdf, 1 sheet)
• Editable Risk Assessment Template (.xlsx, 1 page)

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This document is the final document that is created for the technology transfer. It includes high-level information on all the events that occurred during the transfer.

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• Final Report Template (.pdf, 3 pages)
• Editable Final Report Template (.docx, 3 pages)

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The SOP serves as the overarching document for the execution of technology transfers. This document includes references to most documents that are included during the technology transfer.

Download contains:

• Tech Transfer SOP Template (.pdf, 36 pages)
• Editable Tech Transfer SOP Template (.docx, 36 pages)

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The process flow diagram shows an example of a process flow.

Download contains:

• Process Flow Diagram (.pdf, 3 pages)
• Editable Process Flow Diagram (.vsdx, 3 diagrams)

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This checklist is designed to provide guidance for the planning and execution of technology transfer by outlining sequentially the transfer process in a step-by-step manner. The check list also provides references to key tech transfer documents where applicable.

Download contains:

• Tech Transfer Checklist (.pdf, 5 pages)
• Editable Tech Transfer Checklist (.docx, 5 pages)

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