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
March 26, 2024
EU Pharmaceutical Legislation Reform: Where Are We Now?
On April 26, 2023, the European Commission proposed a new package of pharmaceutical legislation1 to revise many of the currently applicable Regulations. Background This revision is considered by many...
March 25, 2024
Understanding PIPL: Compliance and Implementation Challenges
What is PIPL? Personal Information Protection Law (PIPL) was approved in China on August 20, 2021. It was the first comprehensive data protection legislation in the region. The Law entered into...
March 25, 2024
Achieving Success with Regulatory Intelligence in Pharmacovigilance
What is Regulatory Intelligence in Pharmacovigilance? In Pharmacovigilance (PV), Regulatory Intelligence involves the collection and analysis of publicly accessible PV regulatory guidelines and...
April 18, 2024
ProPharma Now Certified as Medidata Rave EDC Accredited Partner
Leading Research Consulting Organization (RCO) Receives Medidata Accreditation for the RAVE EDC Module, Enhancing Clinical Trial Efficiency and Data Integrity for sponsors. RALEIGH, April 18, 2024 –...
April 10, 2024
ProPharma Announces Changes to Its Executive Leadership Team
Strategic Leadership Appointments to Propel Global Growth RALEIGH, April 10, 2024 – ProPharma, the leading global provider of regulatory, clinical, and compliance services for the life sciences...
January 24, 2024
ProPharma Announces the Appointment of Vicki Gashwiler as Vice President of Clinical Operations, Medical Technology
RALEIGH, January 24, 2024, ProPharma Group (ProPharma), the leading global provider of regulatory, clinical, and compliance services for the life sciences industry, and a portfolio company of Odyssey...
November 27, 2023
EY Announces Michael Stomberg as an Entrepreneur Of the Year® 2023 National Finalist
Entrepreneur Of The Year® celebrates ambitious entrepreneurs who are building a better world. RALEIGH, NC, November 27, 2023 – Ernst & Young LLP (EY US) today announced that Chief Executive Officer,...
October 11, 2023
ProPharma Group Recognized by Everest Group as a Major Contender in Life Sciences Operations PEAK Matrix® Assessment 2023
Raleigh, NC, October 11, 2023: ProPharma Group (ProPharma), the leading global provider of regulatory, clinical and compliance services for the life sciences industry, and a portfolio company of...
August 15, 2023
ProPharma Recognized by Inc. 5000 List of America’s Fastest-Growing Companies
ProPharma Recognized on the Inc. 5000 List of America’s Fastest-Growing Companies After a year of Growth and Innovation, ProPharma achieved its highest rank in 20+ year history. RALEIGH, NC, August...
June 10, 2022
The Cost of Poor Project Management
Project Management isn’t for the faint of heart. There is a shockingly high rate of project failure… but on the other hand, great project management can be a key differentiator that leads a company...
August 31, 2022
Successfully Passing MHRA Inspections for Overseas Manufacturing Sites
ProPharma offers GMP and GDP compliance services from clinical development to commercial distribution of the products' lifecycle. ProPharma’s Compliance and Quality team completed the first on-site...
News & Insights
April 18, 2024
ProPharma Now Certified as Medidata Rave EDC Accredited Partner
Leading Research Consulting Organization (RCO) Receives Medidata Accreditation for the RAVE EDC Module, Enhancing Clinical Trial Efficiency and Data Integrity for sponsors. RALEIGH, April 18, 2024 –...
January 24, 2024
ProPharma Announces the Appointment of Vicki Gashwiler as Vice President of Clinical Operations, Medical Technology
RALEIGH, January 24, 2024, ProPharma Group (ProPharma), the leading global provider of regulatory, clinical, and compliance services for the life sciences industry, and a portfolio company of Odyssey...
November 27, 2023
EY Announces Michael Stomberg as an Entrepreneur Of the Year® 2023 National Finalist
Entrepreneur Of The Year® celebrates ambitious entrepreneurs who are building a better world. RALEIGH, NC, November 27, 2023 – Ernst & Young LLP (EY US) today announced that Chief Executive Officer,...
October 11, 2023
ProPharma Group Recognized by Everest Group as a Major Contender in Life Sciences Operations PEAK Matrix® Assessment 2023
Raleigh, NC, October 11, 2023: ProPharma Group (ProPharma), the leading global provider of regulatory, clinical and compliance services for the life sciences industry, and a portfolio company of...
August 15, 2023
ProPharma Recognized by Inc. 5000 List of America’s Fastest-Growing Companies
ProPharma Recognized on the Inc. 5000 List of America’s Fastest-Growing Companies After a year of Growth and Innovation, ProPharma achieved its highest rank in 20+ year history. RALEIGH, NC, August...
March 25, 2024
Understanding PIPL: Compliance and Implementation Challenges
What is PIPL? Personal Information Protection Law (PIPL) was approved in China on August 20, 2021. It was the first comprehensive data protection legislation in the region. The Law entered into...
March 25, 2024
Achieving Success with Regulatory Intelligence in Pharmacovigilance
What is Regulatory Intelligence in Pharmacovigilance? In Pharmacovigilance (PV), Regulatory Intelligence involves the collection and analysis of publicly accessible PV regulatory guidelines and...