Technology transfer of API from lab to plant is a very critical process for successful API delivery to the client. Diligent planning and execution are required right from selecting plant and equipment, obtaining manufacturing slots, reviewing product development and ensuring the right documentation is delivered on time. At Aurigene, we have a cross-functional team of analysts, chemists, engineers and quality specialists who lead the process of technology transfer. We have extensive experience of scaling up 500+ projects and 1500+ process steps. Our technology transfer procedure from the laboratory to the respective manufacturing facility includes:
Process safety clearance & confirmation of equipment train Analytical method transfers for raw materials, intermediates, in-process tests, and final compound Sharing of process understanding, preparation, and approval of Batch Production Records (BPR)
At Aurigene, we believe in a safe and sustainable manufacturing approach. Controlling chemical reactions and associated hazards is an important aspect of chemical manufacturing. Almost 30% of incidents are caused by chemistry issues due to inadequate study during the developmental phase. Hence, we strive to mitigate hazards and associated risk in scale up by practicing process safety to a great extent.
At Aurigene, there is a very structured methodology for performing process safety. The process includes:
We have internal Standard Operating Procedures (SOP) which govern the analytical method transfer process. Transfers shall be initiated with pre-approved protocols, followed by batch analysis. SOP guides will fix the acceptance criteria for individual tests to conclude the completion of analytical method transfer.
After completion of process optimization, we propose the technology transfer date in consultation with the technology transfer team and technology absorption team.
PR and D, AR and D, and Process Engineering shall submit the development reports to QA three working days before the proposed technology transfer date. QA shall conduct a gate meeting at least two days before the technology transfer date to review the product development of API using a gate checklist (based on the scope of the project, regulatory submissions/GMP requirements etc.) Timelines shall be provided for the pending action items in the gate checklist. Head QA or designee shall decide on the clearance for the technology transfer depending on the pending action items.
Technology transfer shall be conducted based on an optimization study or familiarization report. QA shall hand over all documents along with the technology transfer checklist to the concerned plant QA.
The data generated (document transfer) at the development center will be transferred to the manufacturing facility which would include:
Based on the technology transfer document batch production record to be generated prior to manufacturing start up
After completion of the technology transfer, the required Batch Production Records (BPR) will be generated based on the details provided by the technical team and further will be reviewed and approved by the Quality Assurance (QA) team. Post-completion of the BPR approvals, manufacturing will follow.
We will share the BPR (before it is reviewed and approved by the internal QA team) with the customer team for information purposes only. However, if there are any specific comments from the customer, the BPRs will be further refined as required.
Experience in scale up of 500+ projects or 1500+ stages
Availability of fast accessible non-GMP pilot plant for risk mitigation
Multifunctional technology transfer and absorption core team
JUNE 30, 2022
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