20-22 September 2022
A frequently asked question in product/technology transfer courses is: is a transfer plan a required GMP document?
The question whether a Transfer Plan is a "must have document" from a GMP point of view is already answered with "yes" in the Transfer SOP in most pharmaceutical companies. It should be mentioned here that the aforementioned Transfer SOP is also a "must document" insofar as products are to be transferred, i.e. taken into production or transferred to another manufacturing site.
The times when products were transferred by faxing the manufacturing instructions alone are long gone. Since the major amendment of Chapter 4 of the EU GMP Guide in 2011, the Transfer Plan as well as the Transfer SOP have been included in the list of required documents. Chapter 4.29 states:
"There should be written policies, procedures, protocols, reports and the associated records of actions taken or conclusions reached, where appropriate, for the following examples: [...] - Technology transfer [...]."
"Procedure" means SOP, "protocol" stands for plan.
As expected from a GMP Guideline, there is no indication of the level of detail. These should be described in the Transfer SOP. As a rule, information on the transfer itself (which product, which sites), on the responsibilities and, if applicable, on the regulatory strategy is expected here. Also important are details on the release of the batches produced in the receiving site and which criteria must be fulfilled for the transfer process to be considered complete.
Many other documents are required or useful in a product transfer, but are not considered GMP-required. However, they can be helpful in inspections and audits. These include, for example, project schedules, lists of documents handed over, EHS assessments, etc. However, one should not forget the documents that are essential for a transfer from a GMP perspective: change control on the donor and receiving side.