TECHNICAL TRANSFER FOR GMP APPROVAL.
A technology transfer is required when a pharmaceutical company wants to change from an existing manufacturing site to a new manufacturing site, move from one process train to another, or one facility to another. It is a systematic procedure that is followed to pass the documented knowledge and experience gained during development and or commercialization to another responsible party (the receiving unit) with the demonstrated ability to effectively perform the critical elements of the transferred technology to the satisfaction of all parties and any applicable regulatory bodies.
The technical Transfer process can be daunting especially if you haven’t been through the process before. Our team of specialists ensures this process is carried out in conjunction with other aspects of your project, to save time, expense and difficulties.
WHAT DOES A TECH TRANSFER COVER?
- Transfer of development and production (processing, packaging, and cleaning)
- Transfer of analytical methods for quality assurance and quality control
- Organization and management of the transfer
- Co-ordinating with regulatory and purchasing
- Assessment of premises and equipment
- Documentation, qualification, and validation
- Skills assessment and training
WHAT ARE THE REQUIREMENTS OF A SUCCESSFUL TRANSFER?
- Project plan covering quality aspects based on quality risk management
- The sending unit (SU) and receiving unit (RU) have similar capabilities, facilities, and equipment
- Documented evidence that the RU routinely reproduces the transferred product, process or method against a predefined set of specifications as agreed with SU
- A technical gap analysis which includes a technical risk assessment and potential regulatory gaps effective process and product knowledge transfer
- Legal and economic implications – intellectual property rights, royalties, pricing, conflict of interest and confidentiality
- Problems or issues are communicated from RU to SU
- Continuing knowledge management
- Transparent process
- Trained staff
WHY WORK WITH ICE PHARMA GROUP?
- Access our approved protocols and transfer methods
- We manage the process at every stage right through to first commercial production
- We have the expertise to ensure exact transferred processes
- We take care of coordinating with regulatory, purchasing parties and third-party suppliers
- We save time, internal resources, cost and ensure timelines are met