Isha's GMP Consultancy Private Limited, Chennai - 600 014, India
Mon-Sat 09:00 AM- 18:00 PM
+91 8667589984
Technology Transfer (TT)
Expert Solutions for Successful and Efficient Transfers
Now, more than ever, companies are transferring products and processes from one site to another, often facing limitations on time, resources, and regulatory expectations. Transfers can be complicated and many companies don’t have a comprehensive plan, standard operating procedures (SOPs) or guidelines in place to effectively conduct the technology transfer.
This is where we come in. Our team of multi-functional life science consultants have proven success in managing product and process transfers for our clients.
Let our experts demonstrate how to transfer your product or process in the most efficient manner possible, ensuring compliance along the entire way.
Manageable Milestones for Successful Transfers
- Technology Transfer disciplines are customizable to meet your specific production and technology demands.
- Our approach provides a robust process framework to consistently transfer production technologies from development to production, or from site to site in a compliant and efficient manner.
- Within this framework, certain milestones (or gates) are established upfront to help your leadership team make informed decisions based upon reproducible deliverables, not moving targets.
We shall provide following in the respect of know-how / technology of the product for each product
Raw material specification, quantitative requirements, their sources and their safety data sheets. Product specification and Pharmacopial reference Process details including critical steps, time cycle and process flow chart. Specification of utilities, quantitative requirements and environmental conditions including classification for each stage of processing. SOP, Master Formula / protocol for manufacturing the above products In-process control techniques & in-process control parameters. Analytical testing procedure for raw material as well as finished product. Details of the facilities required for manufacturing of above products giving brief specification. Protocol for Stability study data for the products. Protocol for process validation and analytical validation Demonstrate at least 3 consecutive successful batches. Trouble shooting strategy for deviations in raw material or any process parameter. Any specific storage condition for raw material, in-process material and finished product. Conduct training of operating personnel for technology of product.
Time frame
Time frame for technology transfer product wise will be 6 months for each product (excluding stability study) provided the material and facility is made available at site.