Attention to detail — We Deliver It
A procedure that requires thorough attention to detail, technology transfer refers to the transfer of any process — and also the related documents and accumulated expertise — from a development site to a manufacturing site or between manufacturing sites. WellSpring has the personnel, the experience, the expertise and, most importantly, the process that makes technology transfer smooth and predictable.
Technology Transfers Made Better With WellSpring
To ensure a successful technology transfer, WellSpring forms a collaborative development team comprising the necessary skills and knowledge 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:
- Organization and management of the transfer
- Skills assessment and training required
- Assessment of premises and equipment
- Documentation (specification and other specialized procedures)
- Transfer of development and production records in the areas of processing, packaging and cleaning
- Transfer of analytical methods for quality assurance and quality control
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. Because this is only a transfer between sites, 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.