Manufacturing · Pharmaceutical Industry Practical Discussion

What information is required before starting a technology-transfer project?

The knowledge package a receiving site needs before the first batch.

DGXPComplianceLab Editorial Team18 Aug 20262 min read

• Concept
• Practical example
• Process
• Documentation
• Technology
• Quality considerations
• Example use case

01Concept

Technology transfer moves knowledge, not just documents. The receiving site needs to understand why the process is designed the way it is, which parameters are critical, and what has gone wrong before.

02Practical example

A granulation process transferred to larger equipment needs the development rationale for granulation end-point, not only the set-points used at the sending site.

03Process

1. 1

   Knowledge package assembly

2. 2

   Gap assessment (equipment, materials, methods)

3. 3

   Transfer protocol with acceptance criteria

4. 4

   Analytical method transfer

5. 5

   Trial / exhibit batches

6. 6

   Transfer report

04Documentation

• Development report
• Master formula and batch record
• Specifications and methods
• Risk assessment
• Equipment list
• Deviation and change history

05Technology

Shared document repositories with version control reduce confusion over which documents are current.

06Quality considerations

ICH Q10 treats technology transfer as a lifecycle stage; acceptance criteria must be set before execution, not after.

07Example use case

A readiness checklist reveals that a cleaning method was never transferred; it is added before exhibit batches.

Example use cases are illustrative. This article is general educational information, not regulatory or legal advice.