Transferring Technology in Formulation Development

1) Purpose

The purpose of this SOP is to outline the procedure for transferring technology during the formulation development process, ensuring seamless transfer of knowledge, processes, and documentation from development to manufacturing.

2) Scope

This SOP applies to all formulation development projects within the organization, covering technology transfer activities from initial planning to final transfer completion and documentation.

3) Responsibilities

The responsibilities for this SOP include:
Project Manager: Overseeing the technology transfer process and ensuring alignment with project objectives, timelines, and regulatory requirements.
Formulation Development Team: Documenting processes and preparing transfer packages for manufacturing.
Manufacturing Team: Receiving and implementing transferred technology in manufacturing operations.
Quality Assurance: Reviewing and approving technology transfer protocols, documentation, and outcomes.

4) Procedure

4.1 Technology Transfer Planning

1. Define technology transfer objectives, including product specifications, process parameters, and timelines.
2. Identify key stakeholders and establish communication channels for effective transfer.
3. Develop a technology transfer plan outlining transfer activities, responsibilities, and deliverables.
4. Document the technology transfer plan and obtain approval from stakeholders.

4.2 Documentation and Knowledge Transfer

1. Compile comprehensive documentation of formulation processes, including formulation records, analytical methods, and validation reports.
2. Prepare transfer packages containing detailed instructions, specifications, and critical process parameters (CPPs).
3. Conduct training sessions for manufacturing personnel on transferred processes, procedures, and quality expectations.

4.3 Process Verification and Validation

1. Perform verification and validation activities to ensure consistency and reproducibility of transferred processes.
2. Conduct initial production runs under monitored conditions to verify process performance and product quality.
3. Document verification and validation results, including any deviations and corrective actions taken.

4.4 Technology Transfer Completion

1. Review transfer completion criteria to confirm readiness for routine manufacturing.
2. Obtain final approval from quality assurance and management for full-scale production.
3. Complete transfer documentation and archive records for future reference and audits.

4.5 Post-Transfer Evaluation and Continuous Improvement

1. Monitor manufacturing performance and product quality post-technology transfer.
2. Conduct periodic reviews and audits to identify opportunities for process optimization and improvement.
3. Initiate corrective and preventive actions (CAPAs) as needed to address any identified issues.

5) Abbreviations, if any

SOP: Standard Operating Procedure
CPPs: Critical Process Parameters
CAPAs: Corrective and Preventive Actions

6) Documents, if any

Technology Transfer Plan
Transfer Packages
Verification and Validation Reports
Training Records
Post-Transfer Evaluation Reports

7) Reference, if any

– ICH Q10: Pharmaceutical Quality System
– FDA Guidance for Industry: Technology Transfer – Considerations for Transfer of Manufacturing Site, Change Control, and Documentation

8) SOP Version

Version 1.0