GAMP5 Annex 11 21 CFR Part 11
Chemistry, Manufacturing & Control
Full life cycle
We have the specific scientific and technical capabilities to transfer formulation chemistries from a source unit (SU) to the commercial-scale receiving unit (RU) in compliance with regulatory guidance..
According to Annex 7 of the World Health Organization (WHO) guidelines on the transfer of technology in pharmaceutical manufacturing, technology transfer is defined as “a logical procedure that controls the transfer of any process together with its documentation and professional expertise between development and manufacture or between manufacture sites.” Technology transfers are the formalized and documented process to accomplish the knowledge and documentation transfers of a product. The event can occur at various stages and transitions in a product’s lifecycle including:
• Development to clinical
• Initial launch and commercialization
• Post-market changes
• Market expansions
• Capacity expansions
• External supply
In the planning stage, your tech transfer team will develop a work breakdown structure and outline critical milestones. The planning phase sees the development of the preliminary schedule, as well as generating resource estimates.
Close, open collaboration can help to determine the most suitable course of transfer based on the outcome of risk assessment and understanding of process robustness at scale. It’s at this juncture that the respective parties develop their risk management plans and refine transfer protocols establishing a clear schedule and laying the groundwork for the transition to the execution phase.
In this phase, the program team tracks and manages the project and collects status data. As operational data arrives, the team is prepared to analyze variances and look for adaptive actions to assure quality and process optimization goals. Project status reporting is vital during this phase to ensure transparency and communication and it’s important to partner with a CDMO that prioritizes this.
Technology Transfer will always be a critical and necessary step to the commercialisation or expansion of any drug product set for launch or already on the market.
TT can only be considered successful if there is documented evidence that the RU can routinely reproduce the transferred product, process or method against a predefined set of specifications as agreed with the SU.
Technology Transfer is complex and requires collaboration and extensive planning. BPTC will not only work with your team but will also empower them with the benefit of our extensive Biotech Tech transfer Expertise
