commissioning, qualification, & validation (CQV)
ProPharma has more than two decades of experience commissioning, qualifying, and validating (CQV) manufacturing facilities and processes for regulated clients.
+3,500
Projects Executed
+650
Clients Supported
17 years
Average Staff Experience
+40%
Clients we've supported for over a decade
Industry-leading, Full-Service CQV
We apply our expertise with a risk-based approach to help our clients reach their project goals. Our expert CQV consultants also understand that although this approach can be helpful in minimizing cost and labor, each project is different and requires a tailored approach. Our project managers and subject matter experts have experience working with the different functional teams within manufacturing, validation, and quality to help define the best solution for our clients. The size and strength of ProPharma allows us to rapidly mobilize and demobilize project teams to meet schedule requirements
Why is CQV Important?
Commissioning, Qualification, and Validation (CQV) are essential processes in regulated industries, ensuring compliance, product quality, and safety. They mitigate risks, maintain data integrity, improve efficiency, and support regulatory approvals. CQV also enhances reputation, saves costs, and prioritizes patient safety in healthcare.
Our Commissioning, Qualification, & Validation Services
Validation Program Development
We partner with organizations to develop and implement continuously reliable and compliant validation programs that help clients successfully bring products to market. ProPharma utilizes a scalable/flexible approach to ensure the validation program is right-sized based on clients’ industry, clinical/commercial stage and size.
Gap
Assessments
Our gap assessment process utilizes a planning, execution, and reporting format focused on identifying program gaps and recommended corrective action/remediation.
Facility, Equipment, & Utility Qualifications
Projects ranging in size from small system qualifications to full greenfield/brownfield facility buildouts are routine. Our in-house project managers and SMEs have vast industry experience, transferring knowledge and expertise to the project team to ensure a seamless and efficient approach. Whether it is a single project or a portfolio of CapEx / OpEx projects at a single site, we are built to execute successfully.
Cleaning & Sterilization Validation
Our sterilization services include the physical (IQ and OQ) and microbiological inactivation (PQ) testing aspects for steam sterilization, dry heat, and vaporized hydrogen peroxide.
Our cleaning services involve a defined clustering approach of products, protocols, defined assays and limits, protocol writing, in-test lab selection support, execution of testing support, and reporting that results in effective controls for limiting the bioburden.
Process Validation
ProPharma’s product lifecycle approach towards process validation in pharmaceuticals and biotech helps you deliver optimal product quality by identifying the presence and degree of process variation and the impact variation has on process efficiency and product quality. Minimizing the variation reduces risks and ensures a robust process that reliably produces quality product.
Project Management
Through its internal project management process, ProPharma provides full oversight for validation services or capital project management outsourcing. ProPharma has successfully executed thousands of C&Q projects over the last 20+ years providing various levels of project management focused on schedule, cost, communication, and conflict management.
Staff Support & Outsourcing
At ProPharma, our network of 1,000+ CQV professionals can augment your internal capabilities to ensure project timelines are met utilizing experienced professionals. Our team acts as an extension of your engineering/quality/validation department, while our management team provides you with a direct line of communication for any operational assistance related to the resources deployed.
“Lyell engaged ProPharma as our validation partner as we built and qualified the LyFE Manufacturing Center. ProPharma assisted in all phases of the qualification including establishing the facility and equipment qualification program, protocol generation, protocol execution, and writing the final reports. They played a critical role in getting the facility ready on time and on budget to support the Lyell clinical trials.”
David Shank - Lyell Immunopharma, Inc.
Vice President, Manufacturing
“Lyell engaged ProPharma as our validation partner as we built and qualified the LyFE Manufacturing Center. ProPharma assisted in all phases of the qualification including establishing the facility and equipment qualification program, protocol generation, protocol execution, and writing the final reports. They played a critical role in getting the facility ready on time and on budget to support the Lyell clinical trials.”
David Shank - Lyell Immunopharma, Inc.
Vice President, Manufacturing
Expert Solutions. Proven Results.
With all clients, we take a balanced, risk-based approach to deliver the most current, relevant, and value-added services and recommendations so they can achieve their regulatory compliance and quality assurance goals efficiently and effectively.
FDA & ISO Experience
We have in-depth knowledge of 21CFR Parts 210, 211, 11, & 820 and ISO13485.
Industry Standards & Best Practices
Flexible Approach
Right-Sized Solutions
We provide tailored CQV-related policies and procedures to clients at the level of equipment usage and related regulatory and business risk they need.
Meet Our CQV Experts & Consultants
Kyle Nordstrom
Senior Director, Quality & Compliance, CQV Expert
John Ryan
Senior Director, CQV Expert
Todd Sevier
Associate Director, CQV Expert
Jaime Vaquer-Morales
Senior Project Manager, Cleaning Validation Expert
TJ Stough
Senior Project Manager, Sterilization Expert
Fred Wiles
Principal Consultant, Process Validation Expert
Customized Strategy. Globally Scaled Solutions.
With offices and compliance consultants located around the world, ProPharma offers the capability to execute CQV projects / support in different GxP areas on a global scale, creating efficiency and savings.
News & Insights
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ProPharma Group Named Best Pharmaceutical Regulatory & Compliance Consultancy: 2022 Corporate Excellence Awards
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Congratulations to our 2015 Colleague Award Winners!
Each and every year, it continues to be a company tradition that we take a moment to recognize a select few ProPharma Group colleagues who made a special impact on our company and our clients...
Nov 27, 2023 7:00:00 AM
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Understanding Health Technology Assessment (HTA) authorities’ requirements throughout the product development phase is crucial for a successful market access strategy and planning. This will increase...
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Learn how ProPharma’s Biostatisticians and Programmers enabled a small biotech company to derive more meaningful and actionable insights from their legacy data.
October 19, 2023
Product Quality Complaint Management
Ensuring the safety and health of patients is of utmost significance when it comes to pharmaceuticals, medical devices, and diagnostic programs. This is especially vital in today's intricate and...
November 6, 2023
Tackling Product Quality and Safety Issues through Global Collaboration
See how ProPharma effectively addressed a globally renowned corporation's surge in product quality complaints and financial pressures by establishing a tiered support system, leveraging offshore...