Standard Operating Procedure for Scale-Up Processes in Aerosol Production

1) Purpose

The purpose of this SOP is to outline procedures for the systematic scale-up of aerosol production processes from laboratory-scale to pilot-scale and full-scale production. This ensures consistency, quality, and efficiency in the transition to commercial manufacturing.

2) Scope

This SOP applies to all scale-up activities within aerosol production processes at [Company Name], including formulation scale-up, process optimization, equipment qualification, and validation.

3) Responsibilities

Production Manager: Oversee scale-up activities and ensure alignment with project timelines and production goals.
Process Engineer: Develop scale-up plans and coordinate technical aspects of scale-up activities.
Quality Assurance (QA) Team: Review and approve scale-up protocols, qualification reports, and validation studies.
Regulatory Affairs: Ensure compliance with regulatory requirements throughout the scale-up process.

4) Procedure

4.1 Scale-Up Planning:
4.1.1 Define scale-up objectives, including production capacity, yield targets, and timeline for commercialization.
4.1.2 Conduct feasibility studies and risk assessments to identify potential challenges and mitigation strategies.
4.1.3 Develop a scale-up plan outlining activities, milestones, responsibilities, and resource requirements.

4.2 Formulation and Process Optimization:
4.2.1 Adapt laboratory-scale formulations and processes for pilot-scale and full-scale production.
4.2.2 Optimize critical process parameters (CPPs) and conduct experiments to validate scalability.
4.2.3 Document formulation adjustments, process optimizations, and experimental results.

4.3 Equipment Qualification:
4.3.1 Identify equipment requirements for scaled production and ensure compatibility with process requirements.
4.3.2 Qualify equipment through installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ) protocols.
4.3.3 Document equipment qualification activities and maintain records for regulatory inspections.

4.4 Validation Studies:
4.4.1 Develop validation protocols for critical processes, equipment, and systems involved in scaled production.
4.4.2 Execute validation studies to demonstrate process robustness, reproducibility, and compliance with predefined acceptance criteria.
4.4.3 Analyze validation data and prepare validation reports for review and approval by QA and regulatory authorities.

4.5 Scale-Up Execution:
4.5.1 Implement scale-up plans and monitor production performance against established KPIs.
4.5.2 Conduct periodic reviews and adjustments to optimize production efficiency and product quality.
4.5.3 Address any deviations or issues encountered during scale-up through documented corrective actions.

4.6 Documentation and Reporting:
4.6.1 Maintain comprehensive documentation of scale-up activities, including protocols, reports, and records of changes.
4.6.2 Archive documentation in a controlled documentation system for traceability and regulatory compliance.
4.6.3 Prepare scale-up summary reports for management review and continuous improvement initiatives.

5) Abbreviations, if any

SOP: Standard Operating Procedure
QA: Quality Assurance
CPPs: Critical Process Parameters
KPIs: Key Performance Indicators

6) Documents, if any

Scale-Up Plan
Feasibility Studies and Risk Assessments
Equipment Qualification Protocols and Reports
Validation Protocols and Reports
Scale-Up Summary Reports

7) Reference, if any

FDA Guidance for Industry: Process Validation
ICH Q9: Quality Risk Management
ISO 13485: Medical devices – Quality management systems

8) SOP Version

Version 1.0