Technology Transfer

Question 1

Technology Transfer Def

Answer 1

Activity collection (knowledge/info/skills) that ensures successful relocation of manufacturing process

Question 2

Successful Relocation Def

Answer 2

Receiving unit consistently performs the transferred process in compliance with GMP specifications

Question 3

Sending Unit Def

Answer 3

Disciplines at an organisation where designated API or medicinal product is transferred from

Question 4

Receiving Unit Def

Answer 4

Involved disciplines at an organisation where designated API or medicinal product is being transferred to

Question 5

Technology Transfer Reasons

Answer 5

Reasons occur at every point of natural development lifecycle; more capacity, economic advantages, ect

Question 6

Purpose of Traditional Technological Transfer

Answer 6

Ensures appropriate development info is compiled in detail, transferred quickly and always available

Question 7

What are Technological transfer documents applied to

Answer 7

Form manufacturing process basis, Meets acceptance criteria, Reduce failure (promotes common understanding), Validation & regulatory filling activities and Promotes continual improvement

Question 8

What Is The Most Compliacted Part of Technological Transfer

Answer 8

Clinical Dev (Piolt Scale) and manufacturing scale (full scale)

Question 9

Preapproval TT

Answer 9

Synthesis Dev (lab scale) to Clinical Dev (pilot scale, clinical trials). Also; Clinical Dev (pilot scale) to Manufacturing Site (full scale, commrcial batches)

Question 10

Post Approval TT

Answer 10

Manufacturing Site (full scale) to Manufacturing Site (full scale)

Question 11

TT Team

Answer 11

Multidisciplinary Nature: QA, QC, Production, Engineering, Reg Affairs, Dev labs and Dev departments

Question 12

TT Team Initial Flow of Info

Answer 12

Unidirectional: Sending to Receiving Unit

Question 13

TT Team Main Flow of Info

Answer 13

Bidirectional: Sending and Receiving units

Question 14

TT Phases

Answer 14

Preparation, Implementation, Validation

Question 15

Preparation Phase Outline

Answer 15

Knowledge & info capture from sending unit. Technical process eval, Technical facility eval, Process justification and Receiving unit preparation (prepairing & training). TT report

Question 16

Implementation Phase Outline

Answer 16

Demonstrating; consistency, robustness & understanding of receiving unit. Trial and post trial activities (piolet/commercial scale batches). TT report update

Question 17

Validation Phase Outline

Answer 17

Confirms consistency, robustness and understanding of receiving unit. Validation protocols, reports, manufacture validation, registration btaches. Validation report