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Manufacturing Capabilities
MANUFACTURING CAPABILITIES
McGuff Outsourcing Solutions (MOS) and McGuff Pharmaceuticals, Inc. (MPI) offer full sterile drug manufacturing capabilities including aseptic vial filling, terminal sterilization, method development, analytical testing, environmental monitoring, raw material qualification, and pharmacist-directed 503B oversight. Facilities include refrigerated, controlled-temperature, and light-sensitive storage areas, plus cGMP-compliant shipping for domestic and international distribution.
Aseptic & Sterile Drug Manufacturing
- Semi-automated and automated aseptic vial filling
- ISO-classified cleanrooms designed for 503B sterile operations
- Controlled environments for temperature-sensitive and light-sensitive sterile drug manufacturing
- Pharmacist oversight of sterile production processes and cGMP compliance
- cGMP production aligned with FDA 503B guidance and USP standards
Terminal Sterilization
- Validated terminal sterilization cycles for high-assurance sterility
- Integrated with upstream and downstream quality and production workflows
- Suitable for a wide range of sterile formulations
Method Development & Analytical Testing
- In-house method development and method verification
- Full-service chemical and microbiological QC testing
- Release testing and stability study support
- Documentation managed through controlled quality systems
Environmental & Quality Control Programs
- Complete environmental monitoring program (viable & non-viable)
- Batch record review and quality release executed by QA/QC
- Dedicated QEV, QA, QC departments
- Corporate QA auditor (MCI) providing independent oversight
- Robust validation and continuous quality improvement systems
Product Development & Raw Material Qualification
- MOS-led pharmaceutical product development and formulation design
- Raw material identity verification and supplier qualification
- High-risk suppliers approved by QA/Regulatory and re-audited annually
- Process development to ensure batch-to-batch consistency
Packaging, Storage & Distribution
- Refrigerated, controlled-temperature, and light-protective cGMP storage
- cGMP-compliant shipping area dedicated to finished sterile products
- Temperature-controlled domestic shipping
- International shipping capabilities for qualified products and destinations
