Validation and Qualification
Pharma-Tech Process and Facilities Services provides a broad range of, validation, verification and compliance services to the highly regulated pharmaceutical, biotechnology and medical device industries. Our regulatory and biopharmaceutical best practice know-how, combined with our risk management experience, helps clients achieve the most cost-effective compliance. We excel in project execution and serve as a strategic partner in GMP manufacturing facility qualification. We assist our clients to develop validation master and project plans that best utilize and leverage successful commissioning and verification activities. We work closely with each client to provide the desired level of detail and content to be written within their validation documents. We have an extensive library of engineering, qualification and validation templates, procedures and protocols that allow us to quickly apply our verification test procedures to validation and compliance projects to greatly minimize document development, review and approval time.
Our success stems from our ability to help our clients define appropriates systems boundaries with functional and performance specifications for which the systems and equipment is to be tested and verified. Errors during the functional specification review phase will have a tremendous impact on the efficiency of your validation project execution. It is imperative to catch errors on paper early during the design phase rather than construction or qualification phases.
Our Validation & Qualification capabilities include:
- Validation Project and Master Planning
- Criticality & Impact Assessments
- Risk Assessment and Mitigation
- Change Management
- Protocol Writing and Execution
- Installation Qualification
- Operational Qualification
- Performance Qualification
- Factory and Site Acceptance Testing
- Summary Reports
- GMP Documentation
- Process Validation
- Technical Writing
- Strategic Planning
- Cleaning and Sterilization Validation
- Temperature Mapping – Kaye Validator 2000/Biological Indicators
- Kaye Validator Rental
- DeltaV Computer Software Validation
- Material Verification
- I/O Testing
- Alarms and Security Testing
- Control Loop Testing
- Requalification
- Riboflavin Coverage Testing
- Validation Procedures Training
- Standard Operating Procedures
- 21 CFR Part 11
- GAMP V
- ASTM E 2500
- Detailed Design Specifications
- Functional Specifications
- User Requirements Specifications
- C&Q Leverage strategies
- Process Development
- Leveraging of Process Analytical Technology
- Traceability Matrices
- Quality Assurance
- GDP Review