Technology Transfer Guidelines for Pharmaceuticals

Technology transfer from R&D to manufacturing site is critical because of the scale-up of the product from pilot batch to large-scale commercial batch. A typical technology transfer process can be divided into production part, quality control part and documentation part.

Receiving unit and sending unit both should develop the product transfer protocol jointly to transfer the product related information. Information should be transferred according to the technical expertness of the staff and the manufacturing site capabilities to run the process smoothly.

The material used for manufacturing on receiving unit should have consistency with the material used at the sanding unit. The properties of the raw material those can alter the quality of the product should be identified.

Sending unit should provide the drug master file (DMF) and other related information of the active materials. It may include the following information:

• Flowchart of the manufacturing process of the drug material
• Physical properties including bulk and tap density
• Moisture content including water activity
• Bioburden, endotoxin and sterility as required
• Solubility and pH of solution
• Particle size distribution and its dissolution profile
• Manufacturer and the supply chain of the material
• Other information like heat, light and moisture sensitivity

Excipients also have the considerable effect on the final product so their detailed information should also be provided by the sending unit to receiving unit. It may include the following information:

• Viscosity of material
• Flowchart of the manufacturing process of the drug material
• Physical properties including bulk and tap density
• Moisture content range
• Melting range
• Bioburden, endotoxin and sterility as required
• Ion strength of material
• Solubility and pH of solution
• Specific gravity
• Particle size distribution and its dissolution profile
• Manufacturer and the supply chain of the material
• Compliance with TSE and BSE requirements
• MSDS and heat, light and moisture sensitivity

Sending unit should provide the detailed information of manufacturing process, physical description, specification and in-process controls.

History of the development of the product should also be provided for the further development or process optimization after the successful technology transfer.

Information regarding the environment, health and safety should also be provided to the receiving unit. It should also include the information on product quality review, validation, stability and environmental conditions for manufacturing.

Generally, trial batches are taken at the receiving unit to test the manufacturing parameters and capability of the manufacturing process before running the validation batch.

All the information regarding the packing should be transferred as the manufacturing process. It includes the specification of foils or containers and closures, and other related information as design labeling, artwork and drawings.

To prevent the contamination in the pharmaceutical products, it is essential the follow the adequate cleaning procedure. It can minimize the risk of cross-contamination during manufacturing. Receiving unit should validate the cleaning procedure and sending unit should provide the required information such as existing cleaning procedure, the solubility of all materials, therapeutic dose, the toxicity of the API, cleaning agents and recovery studies.