Standard Operating Procedure for Technology Transfer in Aerosol Production
1) Purpose
The purpose of this SOP is to establish procedures for the systematic transfer of technology, processes, and knowledge from development or existing sites to manufacturing facilities in aerosol production. Effective technology transfer ensures consistency, reliability, and compliance with regulatory requirements.
2) Scope
This SOP applies to all technology transfer activities related to aerosol production processes at [Company Name], including transfers from R&D to production, between manufacturing sites, and from external suppliers.
3) Responsibilities
Technology Transfer Team Leader: Oversee the technology transfer process and coordinate activities between sending and receiving units.
Quality Assurance (QA) Manager: Ensure compliance with regulatory requirements and review/approve technology transfer plans.
Production Manager: Implement technology transfer plans and ensure readiness of production facilities.
R&D Scientist: Provide technical expertise and documentation related to the transferred technology.
4) Procedure
4.1 Pre-Transfer Preparation:
4.1.1 Identify the need for technology transfer and establish objectives and timelines.
4.1.2 Formulate a technology transfer plan outlining roles, responsibilities, and communication protocols.
4.1.3 Conduct gap analysis to identify potential challenges and risks associated with the transfer.
4.2 Documentation and Knowledge Transfer:
4.2.1 Compile comprehensive documentation, including process descriptions, specifications, and critical parameters.
4.2.2 Facilitate knowledge transfer sessions
4.2.3 Review and update documentation based on feedback and insights gained during knowledge transfer.
4.3 Equipment and Facility Readiness:
4.3.1 Assess equipment and facility capabilities at receiving site to ensure compatibility with transferred technology.
4.3.2 Implement necessary upgrades or modifications to meet technical requirements.
4.3.3 Validate equipment and facility readiness through qualification and validation protocols.
4.4 Process Validation:
4.4.1 Develop process validation protocols and perform validation studies to demonstrate consistency and reproducibility.
4.4.2 Collect and analyze validation data to confirm that transferred processes meet predefined acceptance criteria.
4.4.3 Obtain approval from QA and regulatory authorities as required before commercial production.
4.5 Trial Production Runs:
4.5.1 Conduct pilot or trial production runs to evaluate the performance of transferred processes.
4.5.2 Monitor key performance indicators (KPIs) such as yield, product quality, and efficiency during trial runs.
4.5.3 Document findings and address any deviations or issues encountered during trial production.
4.6 Technology Transfer Completion:
4.6.1 Conduct final review and approval of transferred processes and documentation.
4.6.2 Archive all technology transfer documentation in a controlled documentation system for future reference and audits.
4.6.3 Conduct post-transfer reviews to identify opportunities for process optimization and improvement.
5) Abbreviations, if any
SOP: Standard Operating Procedure
QA: Quality Assurance
R&D: Research and Development
KPIs: Key Performance Indicators
6) Documents, if any
Technology Transfer Plan
Process Descriptions and Specifications
Validation Protocols and Reports
Trial Production Run Records
Post-Transfer Review Reports
7) Reference, if any
ICH Q10: Pharmaceutical Quality System
FDA Guidance for Industry: Technology Transfer – Considerations for Quality Agreements
ISO 9001: Quality management systems – Requirements
8) SOP Version
Version 1.0