Tech transfer and scale up

Question 1

The final stages in the development of a new drug product are:

Answer 1

• Transfer of the process and appropriate control tests to the manufacturing site(s) from development, or in some cases transfer between manufacturing sites later in the product lifecycle
  
  • Scale‐up of the process to full scale manufacturing
  • The successful completion of these two stages must be judged by the ability to reliably manufacture on an industrial scale a product that complies with the licensed quality specification and bioequivalent to the material used for clinical studies. To facilitate this, the quality system should require a policy for technology transfer that specifies:
  • Technology transfer plan
  • Communications
  • Objectives for transfers
  • Change Management
  • Acceptance criteria
  • Post transfer activities

Question 2

What should be in a tech transfer plan?

Answer 2

○ What are the timings for transfer?
○ Who will act as the Project Sponsor, Project Manager?
○ Who will constitute the project team?
○ What are the gaps that need to be addressed to ensure effective transfer?

Question 3

What communications are required for a successful tech transfer

Answer 3

s there a procedure to define what should be communicated and how it should be communicated?
○ How is key information transferred?
○ Documentation to be supplied/received?

Question 4

Objectives for tech transfers

Answer 4

○ How will successful transfer be confirmed?
○ How will they be included in personal objectives

Question 5

Tech transfer responsibilities

Answer 5

○ Who is responsible for approving scale‐up as satisfactory?
○ Who has overall responsibility for coordinating the total activity? Often no‐one has overall responsibility. In such cases efficient communication is of paramount importance
○ The quality system should ensure that responsibilities are clearly defined when responsibility passes from one group to another

Question 6

Tech transfer change management

Answer 6

○ What system will be used to assess change
○ How will the technology transfer plan be version controlled and by whom?
○ How will validation and registration activities be addressed?

Question 7

Tech transfer acceptance criteria

Answer 7

○ What criteria are used to determine satisfactory scale‐up at each stage? Is there a procedure to cover this?
○ Time‐based? Based on capability assessment?

Question 8

Post tech transfer activities

Answer 8

○ How long will Development provide support?
○ Who owns any snags that need to be addressed?
○ How is the transfer knowledge captured and disseminated?
○ Change Management