Staff Augmentation Services - Manufacturing Services
Pharma-Tech Process and Facilities Services, LLC provides engineering technical support services in support of virtually all aspects of biopharmaceutical manufacturing operations. Our project management and technical service personnel can identify efficiencies and strategies to streamline cGMP manufacturing with a thorough understanding of complex biopharmaceutical manufacturing processes and a deep understanding of cross-functional organizations, change management and quality systems.
Pharma-Tech Manufacturing Services capabilities include:
- Process and Facility Engineering and Technology
- Aseptic Processing
- Manufacturing Subject Matter Expertise
- Project Management Best Practices
- Good Manufacturing Best Practices
- Cross-Functional Communication
- Organizational Development
- Operational Excellence
- Information Technology
- Owners Representation and oversight
- Technology Evaluation
- Cell Culture and Upstream Processing
- Purification and Downstream Processing
- Formulation and Fill Finish
- Technical Writing
- Design of Experiments
- Technology Transfer
- P&IDs, PFDs, DCFDs, Plan Drawings
- Manufacturing Support
- Equipment Ownership
- Change Control and Management
- Special Projects
- Media Challenge
- Single-Use Disposable Technology
- Material Specification and Certifications
- Bill of Materials
- Batch Records
- Production Troubleshooting
- Deviation Investigation and Closure
- Operational and Process Control Strategy
- Criticality and Impact Assessment
- Risk Assessment and Mitigation
- FDA 483 and Warning Letter Remediation
- Basis of Design (BOD)
- User Requirements Specifications
- Process Characterization and Validation
- Standard Operating Procedures (SOPs) and Guidelines
- CIP/COP
- SIP/Autoclaves
- Filter Integrity Testing
- Equipment Use Logs
- On call support
- Training
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