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Today, there is a higher demand for faster pharma therapies. This results in compressed timelines, leading to more production variance and, ultimately, poorer outcomes. CQV (Commissioning, Qualification, and Validation) pharmaceutical services resolve these challenges by ensuring your systems, equipment, and processes meet stringent regulatory requirements and quality standards—so you can produce safe, effective, and high-quality pharmaceutical products. We specialize in a comprehensive and integrated approach that helps you improve everything from patient safety and product quality to regulatory compliance and overall reputation.
The CQV Pharma Process that Meets Aggressive Timelines
When you partner with us, our team becomes your team. We get to know your internal processes, understand your project requirements, and provide a compliant solution that considers regulatory requirements and industry best practices. Let us help you simplify complexity, assess risks and gaps, and streamline the process to guarantee consistency and efficiency throughout all phases, ensuring compliance with Good Manufacturing Practices (GMP) while meeting aggressive timelines and providing quality service.
PERFORMANCE VALIDATION’S CQV PROCESS:
INPUTS
URS
CLASSIFICATION & RISK
DR / DQ
C&Q TESTING & DOCUMENTATION
ACCEPTANCE & RELEASE
OPERATION
PERIODIC REVIEWOur CQV Capabilities for Optimized Pharma Products
Analysis
Analysis is a fundamental element of the CQV pharma process. Through data-driven analysis, we can guarantee that equipment, processes, systems, and products align with your predefined criteria and regulatory standards.
- Incorporate risk analysis to address potential issues
- Emphasize data integrity through accuracy checks
- Analyze performance data to foster continuous improvement
- Identify areas for optimization
Through our CQV analysis, we can help you with the following:
- ASTM Risk Assessment development and management
- Business Analysis
- Data Analysis
- Regulatory Gap Analysis
- System Risk Assessment
- Time studies
- Verification Business and Quality (CPP/CQA) Risk Assessment Meeting Facilitation and Development
- Design/enhanced design review
- Per GAMP5 for the application of risk to automated or quality systems
- Per ICH Q9 for the use of standard quality tools to facilitate risk based on scientific knowledge & protection of the patient
- Per the ISPE Baseline Guide for system and component classification
Document Creation & Management
The creation of comprehensive documentation is essential to outline protocols, procedures, and specifications for each phase of CQV in pharma. Effective document management is crucial throughout, ensuring that protocols and reports are organized, version-controlled, and easily accessible.
- Provide a transparent record of activities and results
- Facilitate audits with accurate and well-managed documentation
- Streamline inspections and the overall traceability of the CQV process
Our document creation and management experts are available to assist with:
- Change Control Creation/Management
- Commissioning Document Development and Execution
- Electronic Records and Electronic Signatures Development
- Engineering Study Development
- IQ/OQ/PQ Protocol Development
- Non-Conformance and Deviation Development
- Preventative Maintenance Procedure Development
- Procedure and Training Development
- Protocol Development and Execution
- SOP Development
- System Specification / Requirements Development (functional, user, design, configuration)
- Test Script / Protocol Development and Execution (IQ/OQ/PQ/UAT/Regression)
- Validation Master Plans
- Verification/Qualification Protocol
- Master Plan (verification, commissioning, validation, project plan) development & implementation
- Requirements & Specifications Development
Execution
Execution involves the practical implementation of protocols, procedures, and tests outlined during the planning and documentation phases. Productive execution demands meticulous attention to detail, adherence to established procedures, and rigorous testing to verify that systems and processes operate as intended.
- Generate reliable data
- Achieve regulatory compliance
- Ensure product quality and integrity
Count on our team to handle the following tasks:
- Audit/Inspection
- Database Management
- Equipment Function Validation
- Project Execution
- Project Management
- Software Quality Testing
- Temperature Mapping
- Validation/Verification/Qualification
- Verification
- IQ/OQ/PQ Execution
- Verification/ Qualification Protocol
- Change management/ configuration management prior to system turnover and acceptance.
- Development, training, and implementation of Good Engineering Practices to support the commissioning effort
- Formal release/turnover activities and System Acceptance
- Periodic Review (e.g., annual audit) of the qualified systems
- Risk Management
- Testing (Commissioning and Qualification, Verification, Validation, or other testing activities (FAT/SAT))
- Vendor Management, including audit, assessment, and testing
Reporting
Reporting allows us to document and communicate the findings, results, and compliance status throughout each phase of CQV. These reports serve as essential records for regulatory agencies, internal audits, and quality assurance purposes.
- Gain transparency into CQV activities
- Facilitate decision-making
- Enable continuous improvement
- Promote optimization
PV provides detailed reporting for:
- Project Validation Reports
- System Release Report Generation
- Utilities/Environmental Monitoring Trending
Support
Throughout the CQV lifecycle, PV provides support in executing protocols and complying with established standards. Our technical support extends to documentation management, data analysis, and overall project coordination.
- Align with regulatory requirements
- Follow industry best practices
- Enhance organizational standards
Partner with PV for support in:
- Preventative Maintenance program Support
- Preventive Maintenance and troubleshooting
Creating Better GMP Manufacturing Workflows
PV has decades of experience qualifying and validating Pilot, Active Pharmaceutical Ingredients (API), and final production lines for small and large molecules and vaccines using batch and continuous manufacturing processes. With PV’s expertise, you can identify any potential risks or issues in your workflow before they become significant concerns. Our proactive approach helps you minimize downtime and ensure that production stays on schedule, saving time and resources.
Why PV?
The pharma industry is always evolving, and at PV, we keep our team updated with state-of-the-art technology, processes, and techniques. For over 30 years, PV has proven to be a thought leader and expert in novel technologies being adopted by FDA-regulated industries.
- Projects ranging from small system qualifications to multi-million-dollar greenfield manufacturing facilities
- Proven track record of managing every phase of the CQV life cycle
- We work with your SOPs and leverage GMPs to deliver the proper documentation to release quality and safe products to the market
Case Study: mRNA Vaccine Rollout
Challenge
One of our most recent and critical roles was assisting in the successful rollout of the mRNA vaccine with one of the largest pharmaceutical manufacturers in the country. The speed and precision needed to create and produce billions of mRNA vaccines in nine months almost seemed impossible.
Smart Factories for an evolving industry
By collaborating with the manufacturer, PV streamlined processes by validating procedures and equipment in real-time, saving hundreds of hours at the end of the validation process when the vaccine was ready to be distributed.
The rollout of the mRNA vaccine was made possible by seamless collaborations across multiple companies and countries, making “Project Light Speed” a success.
Supporting Smart Factories for an Evolving Industry
The next evolution in manufacturing concepts, Pharma 4.0, or “Smart Factories” as they are often called, is here to stay. PV is proud to be at the forefront, leading top manufacturers in deploying automated storage and retrieval systems (ASRS) and automated guided vehicles (AGV).
By pushing our team to be innovative thinkers, we continually look for new approaches to offer our clients a more efficient validation process without losing sight of the regulations and policies of the regulatory authorities or quality protocols provided by our clients.
Your Dedicated Partner for CQV Pharma Services
As consumer demand for safe, efficacious therapies accelerates, so must the production engine that brings them to market—putting intense pressure on validation timelines and outcomes. We help you streamline using innovative, adaptive approaches that balance production realities with strict regulatory requirements for quality, safety and compliance.
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