Our team will get to know your internal processes, understand your project requirements, and provide a compliant solution that also considers regulatory requirements and industry best practices. We simplify complexity, assessing risks and gaps, and streamline the process to ensure consistency and efficiency throughout all phases, ensuring compliance while still meeting aggressive timelines or budget constraints.
PERFORMANCE VALIDATION’S CQV PROCESS:
GMP Manufacturing Workflows
Your workflow is designed to efficiently transform raw material into a final product in a repeatable, traceable, and compliant way. Our team of experts understands the requirements needed to establish a compliant facility that results in products with the desired quality attributes. 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. From the moment a component arrives at your facility until the final product leaves your shipping department, the team at PV is by your side to assist with all your CQV needs.
The Pharma industry is always evolving, and at PV, we keep our team updated with state-of-the-art technology, process, and techniques. PV has proven to be a thought leader and expert in novel technologies being adopted by FDA-regulated industries.
mRNA Vaccine Rollout
A recent and critical role was assisting in the successful rollout of the mRNA vaccine with one of the largest pharmaceuticals manufacturers in the country. The speed and precision needed to create and produce billions of mRNA vaccines in just a short nine-month period almost seemed impossible. By collaborating with the manufacturer, PV was able to streamline 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 across countries, made “Project Light Speed” a success.
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 out in front leading top manufacturers to deploy Automated Storage and Retrieval Systems (ASRS) and Automated Guided Vehicles (AGV).
By pushing our team to be innovative thinkers, we are continually looking for new approaches to offer our clients a more efficient validation process without losing sight of regulations and policies of the regulatory authorities or quality protocols provided by our client.
Our Skill Areas
- 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
- 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
System Specification / Requirements Development (functional, user, design, configuration)
Test Script / Protocol Development and Execution (IQ/OQ/PQ/UAT/Regression)
Validation Master Plans
Master Plan (verification, commissioning, validation, project plan) development & implementation
Requirements & Specifications Development
Equipment Function Validation
Software Quality Testing
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
Testing (Commissioning and Qualification, Verification, Validation, or other testing activities (FAT/SAT))
Vendor Management, including audit, assessment, and testing
- Project Validation Reports
System Release Report Generation
Utilities/Environmental Monitoring Trending
Preventative Maintenance program Support
Preventive Maintenance and troubleshooting