We have found that there are several important factors often overlooked when considering the transfer of a project from development to manufacture. The implications may not be realised until later in the products life. While processes and paperwork can be easily created as part of a readiness review, subtle nuances and knowledge can be neglected. Knowledge transfer is critical to make sure that staff in production are equipped to manufacture complex, clinical products.
Quality Assurance (QA) is key to measuring the quality of the components of a product. It is also important that R&D;’s experience and critique are transferred to the staff involved in the final Quality Control (QC) of the product.
Bioconnexions Consulting Ltd can review and refine your processes at these critical stages. Our external review and insight can help identify practical issues and highlight steps to mitigate failure.