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)
The following are the steps followed in technology transfer:
Process Safety Clearance and Confirmation of Equipment Train
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:
- Literature data and calculations
- Basic screening tests
- Isothermal calorimetry to find out heat of reaction for process
- Adiabatic calorimetry to examine the runaway potential of reactions and compounds and specific measurements like vent sizing calculations
- Generating Hazard Evaluation Report (HER) for scale up assurance
- Based on the safety evaluation, appropriate engineering controls will be adopted prior to batch processing and they will be captured in the Process Hazards Analysis (PHA) and Process Safety Information (PSI) report.
- Pre-Startup Safety Review (PSSR) will be carried out prior to the start of the batch as a checklist on safety to ensure whether all the safety recommendations are being implemented in the specific manufacturing unit or not. Only after that, batch start-up clearance is given on the specific equipment train.
Analytical Method Transfer for Raw Materials, Intermediates, In-process Tests and Final Compound
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.
Decision on Slots at The Plant
After completion of process optimization, we propose the technology transfer date in consultation with the technology transfer team and technology absorption team.
Stage Gate Meetings
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
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:
- Raw material list along with specifications and method of analysis
- Optimization report or finalized process for the manufacturing
- Holding study data of reaction mass, wet or dry intermediates
- Recovery or reuse of solvent (as applicable)
- Reprocessing or rework procedures (as applicable)
- Details of analytical methods for in-process controls, intermediates and final compound
- Reference standards
- Process flow diagram
- Equipment justification reports
- Details of process safety evaluation and the recommendations
Based on the technology transfer document batch production record to be generated prior to manufacturing start up
Approval of BPR and Start of Manufacture
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.
Why Aurigene Pharmaceutical Services?
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
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Resources
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