Issue link: https://www.e-digitaleditions.com/i/1087673
24 March 2019 Tablets & Capsules Tech transfer charter/proposal The first documentation step is to prepare a tech transfer charter and tech transfer proposal, which are often combined into a single document. The purpose of the tech transfer charter/proposal is to provide a gen- eral framework for the tech transfer and detail its scope. This should also provide an understanding of the key driver(s) behind the transfer (such as cost sav- ings, divesting a product, or changing the CMO that manufactures the product). It's especially important to outline whether or not the sending and receiving units will collaborate on the transfer. I'm often exposed to projects where a drug product is currently being manufactured by one CMO, but the sponsor is qualifying a second CMO to make the product without the current CMO's knowledge. This situation obviously brings an additional level of complexity to the tech transfer project and requires that the communications strategy be clearly laid out in the transfer documents. The charter/proposal should also include a description of the teams and stakeholders involved in the transfer as well as the process, including a high-level list of antici- pated changes (such as sources of materials, equipment, and methods). The charter/proposal will also include the tech transfer's success criteria, such as process validation performed by a deadline for launch in certain territories. Tech transfer package The tech transfer package should contain as much information as necessary to ensure that the receiving unit can successfully complete the transfer on time and within budget. This typically includes the documents listed in Figure 2. People sometimes confuse the package prepared as part of the request for proposal (RFP) with the tech transfer package. The package for RFP only needs to contain enough information for assessing the feasibility and estimating the costs of the transfer, whereas the tech transfer package is much more detailed. It is intended to consolidate all the product and process knowledge necessary for the receiving site to replicate the process in its own facility. If the sending unit or current CMO is not aware of the transfer, I recommend sharing a process flow dia- gram to the receiving unit rather than providing exe- cuted documents. Otherwise, I strongly recommend ask- ing for authorization from the sending unit before sharing documents such as SOPs or manufacturing and packaging records. Risk identification and assessment Implementing a risk assessment strategy and mitigat- ing those risks will bring a robustness to the transfer pro- cess and ultimately prepare it for validation. While I won't go into the details of how to perform a risk assess- ment in this article, I will mention a couple aspects that are important when approaching risk for tech transfer. The International Society for Pharmaceutical Engineering (ISPE) technology transfer good practice guide [1] provides a thorough description of technology transfer documentation. In this article, I'll provide practical information to help scientists or project managers who are new to technology transfer navigate the process and issue their first tech transfer plan. While my emphasis will be on solid oral dosage forms—particularly in the example plan I discuss later—the general approach and structure of a tech transfer plan is the same regardless of the dosage form. The four basic steps for documenting a technology transfer are shown in Figure 1. The steps begin with broad objectives and a high-level timeline and work toward a more detailed assessment and timeline. Figure 1 Tech transfer documentation steps Tech transfer charter/ proposal Tech transfer package Gap analysis/ risk assessment Tech transfer plan Figure 2 Documents included in typical tech transfer package Raw materials and active pharmaceutical ingredient (API) • Manufacturer's certificate of analysis (CofA) • Non-compendial testing methods • Sending unit/registered specifications • API characterization report, recent CofAs Manufacturing process • Recent executed batch records • Master batch record with history of changes • Finished product specifications • Analytical methods, method validation reports • Tooling drawings • Process/cleaning validation reports • Process development report/scale-up report • Copy of module 3 (optional) • List of process-dedicated or process-specific equipment, if any Packaging process • Specifications and/or drawings of primary components • Description of secondary and tertiary packaging components • Executed packaging records Other • Product samples • Stability report: finished product, bulk hold studies • Annual product review, history of changes