Standard Operating Procedure for Clinical Trial Material Production for Aerosols
1) Purpose
The purpose of this SOP is to establish procedures for the production of clinical trial materials (CTM) in aerosol format. This ensures adherence to regulatory requirements, consistency in production, and the generation of reliable data for clinical trials.
2) Scope
This SOP applies to the manufacturing of CTM in aerosol format at [Company Name], including formulation development, scale-up, production, labeling, packaging, and quality control.
3) Responsibilities
Clinical Operations Manager: Oversee CTM production activities and ensure compliance with clinical trial protocols.
Production Supervisor: Manage day-to-day production operations and personnel involved in CTM manufacturing.
Quality Assurance (QA) Team: Review and approve CTM production records, batch documentation, and compliance with GMP.
Regulatory Affairs: Ensure adherence to regulatory requirements and support in the preparation of regulatory submissions.
4) Procedure
4.1 Formulation Development:
4.1.1 Develop aerosol formulations based on clinical trial protocols and regulatory guidelines.
4.1.2 Conduct feasibility studies and preliminary stability testing to select suitable formulations.
4.1.3 Document formulation compositions, manufacturing processes, and critical parameters.
4.2 Scale-Up and Process Validation:
4.2.1 Scale up formulations from laboratory-scale to pilot-scale production.
4.2.2 Validate manufacturing processes through qualification and validation studies.
4.2.3 Document scale-up activities, validation protocols, and reports.
4.3 Production:
4.3.1 Prepare production areas and equipment for CTM manufacturing.
4.3.2 Follow batch manufacturing records (BMR) and standard operating procedures (SOPs) for aerosol production.
4.3.3 Monitor critical process parameters (CPPs) during production and document in-process controls.
4.4 Labeling and Packaging:
4.4.1 Label CTM containers according to clinical trial protocols and regulatory requirements.
4.4.2 Package CTM in suitable containers with appropriate labeling and batch identification.
4.4.3 Conduct reconciliation of labeled CTM batches and prepare for quality control testing.
4.5 Quality Control Testing:
4.5.1 Perform quality control testing on CTM batches, including appearance, assay, content uniformity, and microbiological testing as applicable.
4.5.2 Record and interpret test results, and assess compliance with predefined specifications.
4.5.3 Release or reject CTM batches based on quality control findings and regulatory requirements.
4.6 Documentation and Batch Release:
4.6.1 Maintain complete and accurate documentation of CTM production activities, including BMRs, batch records, and quality control results.
4.6.2 Review and approve batch documentation for release by QA.
4.6.3 Archive CTM production records in a controlled documentation system for regulatory inspections and audits.
5) Abbreviations, if any
SOP: Standard Operating Procedure
CTM: Clinical Trial Material
GMP: Good Manufacturing Practices
BMR: Batch Manufacturing Record
6) Documents, if any
Formulation Development Reports
Scale-Up and Validation Protocols
Batch Manufacturing Records (BMRs)
Quality Control Testing Reports
Batch Release Documentation
7) Reference, if any
ICH E6: Good Clinical Practice
FDA Guidance for Industry: Investigational New Drug Applications
ISO 14644: Cleanrooms and associated controlled environments
8) SOP Version
Version 1.0
