Friday, April 28, 2023

Role of Technology Transfer in pharmaceutical industry

Definition of technology Transfer in pharmaceutical manufacturing: technology Transfer is a process starting a product for commercial or regulatory purpose in a planned facility or unit from R & D or from one facility to other facility, by following a systematic procedure of reviewing, evaluating, documenting and approving through quality assurance, facility, product manufacturing process, equipment, safety data, stability data, analytical method validation, product validation, equipment validation. And documentation of all these activities in a single retrievable, format or a file for the product evaluation and inspection by external and internal auditors or inspectors.
New drug product is developed in research and development department in a pharmaceutical manufacturing company, in research and development department first small scale beaches of a drug product are manufactured. Which are subjected to various studies like, evaluation of content, stability studies of drug product. Evaluation of primary containers, primary packing.
For a commercial launch of a new product these data should be available with review by quality assurance and for clearance for commencement for commercial batches of the product. The technology transfer department or the functions start from this point that is product transferred from research and development to the actual manufacturing facility, or from one facility to other facility for an existing product.
The product transfer has to be done through change management system. 
Change control is filed by tech transfer function for addition of new product in the facility transfer from R and D to manufacturing facility. Sometimes product is transferred from one facility to other facility for manufacturing, first facility may continue to manufacture the product or may discontinue it is the matter planning of manufacturing.
Change control is important part in the technology transfer, change control should evaluate the manufacturing equipment, the available equipment at facility must be checked for the feasibility of the manufacturing of the product. Many times equipment used at R & D level are not matching equipment available shop floor level, therefore detailed report regarding equipment equivalence with R & D and and those available at shoo floor is prepared, just like a comparison sheet.
Quality assurance department evaluate these equivalence of equipment, this is also done for the product transferred from one facility to other facility. Evaluation of equipment, Analytical equipment availability, and analytical methods validations are planned activities written in the change control filed for the technology transfer of the product from R & D or from one facility to other facility. The change control is approved after these things are evaluated and are found in order, in case there is any discrepancy or non-availability of equipment or analytical concerns, these concerns are first cleared by the project management or the production team.
Documentations: activities of Technology transfer department in a pharma company Product information, and manufacturing process, with master batch manufacturing record, master batch packing record are prepared and approved by quality assurance. Details of precautions to be taken by the receiving facility is written down. Approved change control, and the implementation of the action planed in the change control in the technology transfer proposal.
Execution of feasibility batch: Some times before commencing for a commercial batch a batch with actual batch size which is planned as commercial production is taken, and evaluated for its quality and equipment and other requirements of product like analysis method analytical equipment act. During the filing of the change control it is decided to take a feasibility batch, and the same can be commercialized after the complete review and approval for commercialization of the feasibility batch from the quality assurance.
Validation of the product being transferred: Three consecutive validation batches of new technology transferred batches are required to be done for successful transfer of the product.
Deviations: During the actual production or testing of the technology transfer batch, if any deviation is observed it has to be logged, investigated and root cause should be identified and a corrective and preventive action for the eliminating root cause should be taken. 
Certification of completion of technology transfer of the product successfully stated at the facility.

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