Staff Augmentation Services - Validation 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 validation strategies to streamline validation requirements with a thorough understanding of validation and qualification best practices and a deep cross-functional understanding of complex biopharmaceutical manufacturing operations and quality systems.
Pharma-Tech Validation Services capabilities include:
- Process and Facility Engineering and Technology
- MEP and Critical Utility Engineering and Technology
- Validation Subject Matter Expertise
- Validation Project Management Best Practices
- Engineering Best Practices
- Cross-Functional Communication
- Organizational Development
- System, Equipment and Automation Validation
- Process Validation
- Operational Excellence
- Information Technology
- Owners Representation and oversight
- Technology Evaluation
- Aseptic Processing Validation
- Cell Culture and Upstream Processing
- Purification and Downstream Processing
- Formulation and Fill Finish
- Technical Writing
- Design of Experiments
- Technology Transfer
- Factory Acceptance Testing
- Site Acceptance Testing
- 3rd Party Inspection and Verification
- Start-Up and Commissioning
- Validation Support
- Change Control and Management
- Special Projects
- Cleaning Validation and Cycle Development CIP/COP
- Sterilization Validation and Cycle Development SIP/Autoclaves
- Single-Use Disposable Technology Validation
- Validation Protocol Writing and Execution
- Validation Final Reports and Closure
- Bill of Materials
- Project Specifications
- Design Specifications
- Material Specifications
- Batch Records
- Validation Troubleshooting
- Cross-Functional Communication
- Criticality and Impact Assessment
- Risk Assessment and Mitigation
- FDA 483 and Warning Letter Remediation
- ASTM 2500
- Integrated Commissioning and Qualification Strategies
- Basis of Design (BOD)
- User Requirements Specifications
- Functional Requirements Specification
- Design Qualification
- Receipt, Installation, Operation and Process Verification Testing and Reports
- Installation, Operation and Process Qualification Testing and Reports
- Standard Operating Procedures (SOPs) and Guidelines
- Cleanroom Operation and Qualification
- Process Validation Runs and Media Challenge
- Training
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