Keen attention to detail
With extensive experience in technology transfer, ANI Global Source has a deep understanding of the process and offers years of accumulated expertise. Our personnel, experience, expertise and process makes technology transfer smooth and predictable.
To ensure a successful technology transfer, ANI Global Source forms a collaborative development team to ensure that the technology transfer occurs successfully and in a timely manner. Our team develops a written control strategy that considers all the possibilities and focuses attention on critical points in the process and equipment. Additionally, we review the process flow for inputs and outputs that may impact quality. Finally, we track the key metrics such as repeatability and precision to ensure success.
To be successful, the receiving entity must demonstrate to the satisfaction of the regulatory bodies both the knowledge and the capabilities to perform the critical elements of the transfer.
Critical Areas That Must Be Considered:
Site-to-Site Technology Transfer
When performing a site-to-site technology transfer, personnel with the knowledge and experience of the product must assist in the transfer training, guidance and assessment for the internal receiving site.
Documentation concerning the processing, packaging, cleaning validation, analytical methods and associated procedures must be readily available. Manufacturing equipment capabilities and capacities should already be known and no external approvals of documents or external technical support would be required.
Limited documentation with older pharmaceutical products has the potential to hinder a smooth transfer. Historical experience for the product may not be available as the product to be transferred may be an acquisition of an old product, but the existing site should be willing to share whatever experience is available.
Additionally, older products to be transferred may have utilized outdated technology and may require modification or enhancement to be suitable. In these cases, the supplemental post approval changes (SUPAC) should be reviewed, and all documentation reproduced and approved by external units. ANI Global Source has the experience and expertise to assist these processes and support the tech transfer process in all stages.