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Technology Transfer Guidelines for Pharmaceuticals


Technology transfer process in pharmaceuticals from one manufacturing unit to another or from R&D to manufacturing unit.
Technology transfer is the process by which the manufacturing process and analytical method is transferred from one manufacturing unit to another unit or from R&D to manufacturing unit.

Tech transfer

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.

A) Production: Technology Transfer
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.

1. Raw Materials:
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 product should be identified.
i) Active Pharmaceutical Ingredients (API):
Sending unit should provide the drug master file (DMF) and other related information of the active materials. It may include the following information:
  • Flow chart 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 as heat, light and moisture sensitivity

ii) Excipients:
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:
    Tech transfer flow chart
  • Viscosity of material
  • Flow chart 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 for TSE and BSE requirements
  • MSDS and heat, light and moisture sensitivity

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

3. Finished Products
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.

4. Packing Process
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.

5. Cleaning Process
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, solubility of all materials, therapeutic dose, toxicity of the API, cleaning agents and recovery studies.

6. Manufacturing Facility
Sending unit should provide the information related to the facility design.
i) Premises
It should include the layout of facility, buildings, utility services, fire risk, health and safety requirements for operators and environmental issues.
ii) Equipment
A list of required equipments with their make and models should be provided by the sending unto. It should include the manuals, drawings and cleaning, operating and maintenance procedures. IQ, OQ and PQ of the equipments should be done by the receiving unit.

B) Quality Control: Analytical Method Transfer
Analytical method has its own importance because the manufactured product shall be tested by the developed analytical method and accuracy in analytical method can save time. Receiving unit should implement the method of analysis for finished product, raw materials, packing materials and cleaning residues before the starting of the process validation.

Analytical method transfer protocol should be prepared including responsibilities of both sanding unit and receiving unit, specification of product, acceptance criteria, interpretation of results, report formats, reference standards and deviations during analysis. Training should be provided to the analysts and should be documented in training record.

C) Documentation
Every step followed during the technology transfer process should be documented and a summary report should be prepared containing the conclusion of the technology transfer. Discrepancies found during the process should be listed and should be resolved by taking the appropriate action. Following documents should be prepared during the successful tech transfer.
  1. Technology transfer protocol
  2. Facility qualification protocol and report
  3. Equipment qualification protocol and report
  4. Process validation protocol and report
  5. Cleaning validation protocol and report
Related: Download the Detailed Document
Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
Email: .moc.enilediugamrahp@ofni Need Help: Ask Question


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