- Process flow -
Core team formation
Each project has a dedicated project team with representatives from each department. This project team will be involved from the Technology Transfer to Clinical Manufacturing and ensure that additional operators will be trained with increased capacity demands.
Technology information captured in Transfer list
The technology transfer list is a tool to help clarify and define all aspects of manufacturing, testing, release and distribution of the client’s Cell Therapy Product. With this list, it is the objective to describe all requirements for materials, equipment, documentation, logistics, HR and validation in order to manufacture, test and release the customer’s product. Furthermore, information related to the Product Dossier is also required related to qualification- and/or validation status of the processes and development studies.
Risk Assessments performed & Plan for mitigation
Risks need to be identified and anticipated for prioritization. Changes maybe proposed to reduce the chance of problems occurring related to such risks. A qualification program will be drafted and agreed for training of operators from different operational departments that includes a proof of competency aspect. Operators that are trained need to meet certain qualification parameters to prove to the client the qualification status that will be recorded in training records.
TT protocol drafted
Protocol in which the mutual responsibilities of PharmaCell and the Customer are defined, pitfalls are identified and initial timelines for the tech transfer are laid down. This document defines the scope of the technology transfer. Readiness checks are performed in which the following aspects are addressed:
Demonstration, Verification & Qualification process
During these runs, all in process and final QC tests must be performed, first in demonstration stage, followed by verification stage and finally confirmed in qualification stage. Documentation is tested during these runs
Draft, Test, Review & Approve GMP Documentation
Using the documentation provided by the customer in the information exchange phase and the findings of the demonstration runs, PharmaCell will create documentation compliant to all relevant standard procedures in the Quality System.
Method Transfer & QC Assay Validations
Method transfer and validation of QC methods can be performed during qualification runs to be able to use validated QC methods during process validation. If this is the case, all documents that are used in validation of QC methods or any other validation, need to be effective and in the Documentation Management System before initiation of the manufacturing run(s).
For implementation of new equipment, a User Requirement Specification needs to be agreed upon. Installation, Operation and Performance Qualifications need to be agreed and executed
Aseptic Operator Qualification
Operators will be qualified for aseptic handling in compliance to all open handlings in the manufacturing process as described in the training proficiency
Phase Evaluations: Validation ReadinessReadiness checks are performed in which the following aspects are addressed:
Aseptic Process Validation
The Aseptic Process Validation will demonstrate that the manufacturing process to be performed in the PharmaCell manufacturing facility can be done in an aseptic manner.
The Process Validation will demonstrate that the manufacturing process to be performed in the PharmaCell manufacturing facility can be done in a consistent and GMP compliant manner.
Phase Evaluation: Clinical Readiness
Readiness checks are performed in which the following aspects are addressed: