The success of technology transfer depends on the provision of information and data by the “sending location” to the “receiving location”. The information required is recoded and submitted in module 3 of a CTD, but at a greater level of detail and volume, including:
- Equipment specification (DQ, IQ, OQ, PQ) and operating ranges
- Manufacturing process steps/ stages / specifications (manufacturing Instructions)
- Validation Master Plans (VMP) and Validation Reports
- Raw materials suppliers, specifications, and storage / use conditions
- Analytical test methods, equipment used, and specifications
- Training materials
Meeting with the regulatory agencies is advised to discuss any specific requirements and to identify the relevant regulatory framework to be used for the registration of the technology transfer. This may include simple license variations and supplements, through to comparability and equivalence protocols.
Acceptance criteria for individual parts of the technology transfer, as well as the overall success measures, should be agreed in advance.