Technology Transfer

GOOD DOCUMENTATION PRACTICE (GDocP)
1

Dear Friend

What are the basic requirements of technology transfer?

What are the various steps to be taken care if we transfer a product from MHRA approved facility in UK to a new facility in Asia. What is the level of documentation required from both the party.

Rgds//DJS

2

Hi

Do you mean analytical method transfer?

3

An approved protocol will be sent from UK to asia, That contains,

Number of batches and tests to be analysed in asia.

The results of these batches are compared with the results(same batches analysed at UK) from UK.

If the acceptance criteria is met. the analytical method transfer is completed successfully.

In this case, No method validation or method verification is required.

the samples and standards for the method transfer are offered by UK only.

A dossier will be sent from UK to asia [ dossier means :complete guide for a product contains Mfg,Chemistry, controls, Packing, Validation]
In case of mfg, the Pilot scale batches are manufactured in local R&D and tested for integrity.

Then Scale up batches are manufactured with the Approval from transferrer.

Regards,
Bujji kanchi.

Regards,

Bujji Kanchi.

4

When you transfer any technology it is necessary to compare process and engineering aspects.
Due to suitability of location , the parent organization might take reccomendations from company in other region.
There might be a change in equipment or design of an equipment or new technologies might be tried.
In most of cases 100% reproducability of facility is near impossible.
They try to keep certain set of critical materials constant and change other non-critical elements.
During this change all the equipments, Processes, Procedures, Environmental conditions and flows are compared with the process and conditions that are done at technology site.
This is the time taking issue during pilot studies.
The time depends up on the criticality of manufacturing process and quality criticality of produced drug substance or Drug product.
During this the team from both companies will be observing and noting that all the Equipments-Instruments-Utilities-Flows and Processes will be in a STATE OF CONTROL to achieve Desired quality product which matches the required Critical Quality Attributes.
After repeated experiments a dossier will be prepared.

The above post missed a critical point in Shipping Validation.
This is very essential and crucial when a product is transfered from UK to Asia due to change of climatic and Transporting conditions.