Issue link: https://www.e-digitaleditions.com/i/1087673
28 March 2019 Tablets & Capsules but rather a valuable tool that the project manager or technical lead maintains from the project inception up to the completion of all activities. Following the disciplined approach I've described in this article can help pharma- ceutical companies and CMOs increase the success rate of future technology transfer projects. T&C References 1. ISPE, Good Practice Guide: Technology Transfer, Third Edition (2018). https://ispe.org/publications/guidance- documents/good-practice-guide-technology-transfer- 3rd-edition. Anthony Grenier is an independent technology transfer and outsourcing consultant (techtransfer@anthonygrenier.com). He is a chemical engineer by training and has conducted more than 50 technology transfers for large multinational corpora- tions and specialty and virtual pharmaceutical manufacturers. His work spans all major segments of the life science industry. process validation documents. We also used the tablets generated at this stage to assess the packaging tooling prior to qualification and determine whether a new tool- ing or packaging configuration was required. Other studies. We also performed a process validation, cleaning verification/validation, bulk holding time, and packaging validation studies. 7. Conclusions In this case, we concluded that changing the active ingredient supplier will justify performing and budgeting for pilot batches and pre-market stability studies. These lots would also allow the receiving site to confirm that the sticking issue was not present at pilot scale, though it would still need to be monitored at larger scale. 8. Attachments This section includes any attachments used to prepare the tech transfer plan. In this case, we included formal documents such as process validation reports from the sending site along with meeting minutes for key project decisions and the initial risk assessment. Conclusion A tech transfer plan is a living document that captures all activities, changes, and risks involved with a technol- ogy transfer. It should not be something that you gener- ate at the beginning of a transfer process and then forget,