Explaining the need of technology transfer in pharmaceuticals

What is technology transfer?

• Defined as a “logical procedure that controls the transfer of any process together with its documentation and professional expertise between developments or between manufacture sites or its Contract Manufacturing Organisation (CMO)”.

• Provides efficiency in process, maintains quality of product, helps achieve a standardised process which facilitates cost effective production.

Key reason for technology transfer

• Due to the lack of manufacturing capacity, the developer of technology may only have manufacturing equipment which is suitable for small scale operation, and must collaborate with another organisation to do large scale manufacturing.

Importance of technology transfer expertise

• Clarifies necessary information to transfer technology from R&D to actual  manufacturing by sorting out various data obtained during R&D.

• Demonstrates necessary information to technology transfer from R&D to actual manufacturing.

• Clarifies necessary information to transfer technology of existing products between various manufacturing places.

• Exemplifies specific procedures and points of concern for the smooth manufacturing of commercialised products.

Basic policies for technology transfer

• Assures consistency through all the separate development and manufacturing steps.

• Implements of Quality by Specifications.

• Provides documentation and updates of technical information.

Essential steps in technology transfer

The following steps are needed in the course of the transfer of APIs or Finished Products between two sites:[1]

1. A technology transfer plan: outlines all transfer activities and responsibilities in detail.

2. Detailed process information at the receiving unit: this is especially necessary when dealing with a new CMO or an unfamiliar type of product.

3. Gap analysis report: technical gap analysis exercise between the receiving and sending site. This determines whether key elements such as equipment, raw material specifications and packaging materials are like-to-like, comparable or need to be changed or adjusted at the receiving unit.

4. Analytical methods transfer: a stability indicating method should already be in place for testing small-scale or engineering batches. An early start to assessing representative sample under accelerated stability is essential.

5. Preparation of master batch records: prepared at the receiving site and then reviewed by the sending unit. This documentation will assist the operator at the receiving site to perform the right handling or adjustments.

6. Risk assessments: This predicts the multiple critical areas from materials to drug product manufacturing and packaging through drug substance process and will be confirmed during pre-validation batches.

7. Health and Safety Review: conducted to ensure the ability to safely handle the raw material and the final product.

8. Training of work force at receiving unit: involves training the analysts and operators who are helping the technology transfer to be successfully completed.

9. Cleaning validation needs to be assessed and reported.

10. Technology transfer report: a key document that will include a justification for the proposed process parameters and their criticality.

11. Process validation: The step we have to approach with all uncertainties already covered in the previous steps.

Summary

Technology transfer means action to transfer of information and technologies necessary to realise quality of design of drugs during manufacturing. The three primary considerations to be addressed during an effective technology transfer are the plan, the persons involved, and the process.