commissioning, qualification, & validation (CQV)

ProPharma has more than two decades of experience commissioning, qualifying, and validating (CQV) manufacturing facilities and processes for regulated clients.  
GxP Audits Header GxP Audits Header

+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.

Woman using machinery and holding laptop

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.

quality-compliance

FDA & ISO Experience

We have in-depth knowledge of 21CFR Parts 210, 211, 11, & 820 and ISO13485.

compliance

Industry Standards & Best Practices

Leadership and direct contributions to the development of industry best practices and standards, including ISPE, GAMP5, and ASTM.
commission-qual-validation

Flexible Approach

 We have experience working within the framework of multiple client quality systems, policies, and procedures to exceed specific validation and project implementation requirements in a timely and cost-effective manner.
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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 Bio Photo

    Kyle Nordstrom

    Vice President, Compliance & Quality Assurance

  • John Ryan Bio Photo

    John Ryan

    Senior Director, CQV Expert

  • Todd Sevier Bio Photo

    Todd Sevier

    Associate Director, CQV Expert

  • Jaime Vaquer-Morales Bio Photo

    Jaime Vaquer-Morales

    Senior Project Manager, Cleaning Validation Expert

  • TJ Stough Bio Photo

    TJ Stough

    Senior Project Manager, Sterilization Expert

  • Fred Wiles Bio Photo

    Fred Wiles

    Principal Consultant, Process Validation Expert

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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

What is a LIMS, and How Do I Know if I Need One?

June 20, 2024

What is a LIMS, and How Do I Know if I Need One?

Learn about Laboratory Information Management Systems (LIMS) and Electronic Lab Notebooks (ELNs), and how to determine if your lab needs one.

Meet the Expert: David Lough

June 19, 2024

Meet the Expert: David Lough

Meet the Expert: David Lough, a Senior Pharmacovigilance Consultant at ProPharma, shares insights on PSMF and robust quality management systems.

An Overview of the PSMF: Pharmacovigilance System Master File

June 17, 2024

An Overview of the PSMF: Pharmacovigilance System Master File

Learn about the Pharmacovigilance System Master File (PSMF) in the EU, its history, structure, updates, and outsourcing options.

ProPharma Receives 2024 CRO Leadership Award

June 13, 2024

ProPharma Receives 2024 CRO Leadership Award

ProPharma wins 2024 CRO Leadership Award for exceeding expectations in key categories, solidifying its position as a top global research consulting organization in the life sciences industry.

Revolutionizing Patient Care: ProPharma and PBL Launch Innovative Cell & Gene Therapy Manufacturing Device

May 2, 2024

Revolutionizing Patient Care: ProPharma and PBL Launch Innovative Cell & Gene Therapy Manufacturing Device

ProPharma and PBL introduce Cell Factory Box for decentralized Cell & Gene Therapies manufacturing, reducing costs and improving patient access to life-saving treatments.

ProPharma Now Certified as Medidata Rave EDC Accredited Partner

April 18, 2024

ProPharma Now Certified as Medidata Rave EDC Accredited Partner

ProPharma receives Medidata Rave EDC accreditation, enhancing clinical trial efficiency. Learn about the latest milestone delivering cutting-edge solutions.

ProPharma Receives 2024 CRO Leadership Award

June 13, 2024

ProPharma Receives 2024 CRO Leadership Award

ProPharma wins 2024 CRO Leadership Award for exceeding expectations in key categories, solidifying its position as a top global research consulting organization in the life sciences industry.

EY Announces Michael Stomberg as an Entrepreneur Of the Year® 2023 National Finalist

November 27, 2023

EY Announces Michael Stomberg as an Entrepreneur Of the Year® 2023 National Finalist

Ernst & Young announces Michael Stomberg as a finalized for Entrepreneur Of The Year® 2023 National Award to celebrate ambitious entrepreneurs.

ProPharma Group Recognized by Everest Group as a Major Contender in Life Sciences Operations PEAK Matrix® Assessment 2023

October 11, 2023

ProPharma Group Recognized by Everest Group as a Major Contender in Life Sciences Operations PEAK Matrix® Assessment 2023

Everest Group has recognized ProPharma Group as a Major Contender in Life Sciences Operations PEAK Matrix® Assessment 2023.

Infographic The Cost of Poor Project Management - ProPharma

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...

Infographic Successfully Passing MHRA Inspections for Overseas Manufacturing Sites - ProPharma

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...

Infographic Navigating the Generic Drug Application and Approval Process - ProPharma

October 4, 2021

Navigating the Generic Drug Application and Approval Process

Navigating the generic drug application and approval process can be challenging. From pre-filing through post-approval, find out exactly what needs to be done for your Abbreviated New Drug...

News & Insights

ProPharma Receives 2024 CRO Leadership Award

June 13, 2024

ProPharma Receives 2024 CRO Leadership Award

ProPharma wins 2024 CRO Leadership Award for exceeding expectations in key categories, solidifying its position as a top global research consulting organization in the life sciences industry.

Revolutionizing Patient Care: ProPharma and PBL Launch Innovative Cell & Gene Therapy Manufacturing Device

May 2, 2024

Revolutionizing Patient Care: ProPharma and PBL Launch Innovative Cell & Gene Therapy Manufacturing Device

ProPharma and PBL introduce Cell Factory Box for decentralized Cell & Gene Therapies manufacturing, reducing costs and improving patient access to life-saving treatments.

ProPharma Now Certified as Medidata Rave EDC Accredited Partner

April 18, 2024

ProPharma Now Certified as Medidata Rave EDC Accredited Partner

ProPharma receives Medidata Rave EDC accreditation, enhancing clinical trial efficiency. Learn about the latest milestone delivering cutting-edge solutions.

Previous Post Arrow Next Post Arrow
ProPharma Receives 2024 CRO Leadership Award

June 13, 2024

ProPharma Receives 2024 CRO Leadership Award

ProPharma wins 2024 CRO Leadership Award for exceeding expectations in key categories, solidifying its position as a top global research consulting organization in the life sciences industry.

EY Announces Michael Stomberg as an Entrepreneur Of the Year® 2023 National Finalist

November 27, 2023

EY Announces Michael Stomberg as an Entrepreneur Of the Year® 2023 National Finalist

Ernst & Young announces Michael Stomberg as a finalized for Entrepreneur Of The Year® 2023 National Award to celebrate ambitious entrepreneurs.

ProPharma Group Recognized by Everest Group as a Major Contender in Life Sciences Operations PEAK Matrix® Assessment 2023

October 11, 2023

ProPharma Group Recognized by Everest Group as a Major Contender in Life Sciences Operations PEAK Matrix® Assessment 2023

Everest Group has recognized ProPharma Group as a Major Contender in Life Sciences Operations PEAK Matrix® Assessment 2023.

Previous Award Arrow Next Award Arrow
What is a LIMS, and How Do I Know if I Need One?

June 20, 2024

What is a LIMS, and How Do I Know if I Need One?

Learn about Laboratory Information Management Systems (LIMS) and Electronic Lab Notebooks (ELNs), and how to determine if your lab needs one.

Meet the Expert: David Lough

June 19, 2024

Meet the Expert: David Lough

Meet the Expert: David Lough, a Senior Pharmacovigilance Consultant at ProPharma, shares insights on PSMF and robust quality management systems.

An Overview of the PSMF: Pharmacovigilance System Master File

June 17, 2024

An Overview of the PSMF: Pharmacovigilance System Master File

Learn about the Pharmacovigilance System Master File (PSMF) in the EU, its history, structure, updates, and outsourcing options.

Previous Post Arrow Next Post Arrow
Infographic The Cost of Poor Project Management - ProPharma

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...

Infographic Successfully Passing MHRA Inspections for Overseas Manufacturing Sites - ProPharma

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...

Infographic Navigating the Generic Drug Application and Approval Process - ProPharma

October 4, 2021

Navigating the Generic Drug Application and Approval Process

Navigating the generic drug application and approval process can be challenging. From pre-filing through post-approval, find out exactly what needs to be done for your Abbreviated New Drug...

Previous Resource Arrow Next Resource Arrow