PROCESS LIFECYCLE VALIDATION - Risk Management Applications in Pharmaceutical and Biopharmaceutical Manufacturing - page 204

document that the processes operate comparably and produce comparable prod-
ucts. Evaluation of historical data from multiple commercial manufacturing sites
may be included in this assessment.

8.8.1 Technology Transfer

The goal of technology transfer activities is to transfer product and process
knowledge between development and manufacturing, and within or between
manufacturing sites to achieve product realization [17]. The transfer must
demonstrate comparability of the product and process between the donor and
recipient sites. Changes to the recipient site facility, equipment, or automation
systems, and process should utilize quality approved change control processes
during all phases of the transfer. Verification of GMP readiness of the equipment
and systems is required before manufacturing of commercial-scale batches.
The process transfer should follow a structured process with defined milestones
as described in a master transfer plan (MTP). The level of detail in the MTP
documentation should be commensurate with the level of complexity of the
transfer and should include the following elements: objective, scope, governance
structure (i.e., management and decision-making responsibilities), transfer

responsibilities, transfer acceptance criteria, transfer deliverables, and target

dates.
Transfer deliverables should include (but not be limited to) the following:

• QC methods transfer report;
• raw materials transfer report;
• equipment/systems assessment, including materials of construction and capa-
bilities;
• risk assessments;
• recipient site manufacturing batch records and SOPs;
• validation summary reports (e.g., equipment, automation, cleaning, process);
and
• MTP summary report confirming that acceptance criteria for the transfer
have been met and the process has been successfully transferred.

There may be multiple RAs associated with a technology transfer (e.g., RAs for
process changes, facility and equipment changes, method transfer, multiproduct
operations, etc.). Therefore, it is important that QRM activities are adequately
planned; this QRM planning can be incorporated into the MTP. As noted earlier,
the risk-based approach may be qualitative (e.g., technical rationale, checklist,
decision tree, etc.) or may involve the use of specific scoring tools (e.g., PHA,
FMEA, etc.). When risk scoring methodologies are used, it is important to ensure
consistency in the scoring and risk evaluation (e.g., risk priority number (RPN)
matrix) criteria used for all transfers. Given here are some risk management
activities that may be useful in a typical technology transfer. QRM application