Clinical Trial Material Manufacturing in Formulation Development
1) Purpose
The purpose of this SOP is to establish procedures for the manufacturing of clinical trial materials (CTMs) in formulation development, ensuring adherence to Good Manufacturing Practices (GMP), compliance with regulatory requirements, and facilitation of clinical trials.
2) Scope
This SOP applies to the manufacturing activities conducted within the formulation development department of the organization, covering the formulation, production, testing, packaging, labeling, and release of CTMs for clinical trials.
3) Responsibilities
The responsibilities for this SOP include:
Formulation Development Team: Developing formulations, overseeing manufacturing processes, and ensuring product quality.
Manufacturing Operations: Executing manufacturing activities, maintaining production records, and managing inventory.
Quality Assurance: Monitoring GMP compliance, conducting batch reviews, and approving CTM release.
Regulatory Affairs: Providing regulatory guidance, ensuring documentation compliance, and supporting regulatory submissions.
Clinical Operations: Coordinating clinical trial supply chain, managing CTM distribution, and ensuring trial site readiness.
4) Procedure
4.1 Formulation Development
- Develop and optimize formulations suitable for clinical trial materials, considering stability, safety, and efficacy requirements.
- Document formulation development activities, including composition, manufacturing process, and critical quality attributes.
- Conduct feasibility studies and pilot batches to validate formulations before scaling up for CTM manufacturing.
4.2 Manufacturing Process
- Prepare manufacturing instructions (batch records) detailing procedures for CTM production, including equipment setup, raw material handling, and process parameters.
- Execute manufacturing operations under controlled conditions, adhering to GMP guidelines and following approved batch records.
- Monitor critical process parameters and perform in-process testing to ensure product quality and consistency.
4.3 Testing and Quality Control
- Collect samples during manufacturing for in-process testing and quality control analysis, including identity, purity, potency, and stability testing.
- Perform analytical testing and review results to confirm compliance with specifications and release criteria.
- Document testing procedures, results, and batch records in compliance with GMP and regulatory requirements.
4.4 Packaging and Labeling
- Prepare packaging materials and labels according to approved specifications and regulatory requirements.
- Package CTMs under controlled conditions to prevent contamination, maintain product integrity, and ensure traceability.
- Label CTMs accurately with required information, including product name, strength, dosage form, batch number, expiration date, and storage conditions.
4.5 Release and Distribution
- Conduct final batch review and approval based on compliance with specifications, GMP requirements, and regulatory submissions.
- Release CTMs for distribution to clinical trial sites, ensuring proper documentation, labeling, and shipment tracking.
- Coordinate with clinical operations to manage CTM supply chain, monitor inventory levels, and address supply issues as needed.
5) Abbreviations, if any
SOP: Standard Operating Procedure
CTM: Clinical Trial Material
GMP: Good Manufacturing Practice
6) Documents, if any
Formulation Development Reports
Batch Records
Testing Certificates
Packaging and Labeling Specifications
7) Reference, if any
– FDA Guidance for Industry: Investigational New Drug Applications (INDs) — Chemistry, Manufacturing, and Controls Documentation
– ICH Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
8) SOP Version
Version 1.0
