Preapproved test plan

A. Preapproved Test Plan/Standard Operating Procedure/Protocol... 

The process validation protocol is a preapproved written plan stating how the validation will be conducted and identifying acceptance criteria as well as sampling and assay requirements [33] and other testing details [3]. It is a prospective experimental plan that when executed produces documented evidence that the system has been validated [25]. The protocol defines the system to be validated, identifies operating variables and probable control parameters, and indicates the number of... 

The importance of master plans in the technology transfer process is described by MacLennon Troll. While the master plan is specifically described for the technology transfer process as a whole, it is also applicable to the transfer of analytical methods and its use is becoming more prevalent within the industry. The technology transfer master plan describes the transfer strategy for all of the testing methods described in the specifications for the test article(s) of interest. The master plan is an auditable document that will help the health authorities during the preapproval inspection (PAI) to understand the overall transfer process and make... 

---