CQV Explained: A Practical Guide for Pharma, 503Bs & CGT
Getting CQV right ensures your systems, processes, and people consistently deliver safe, high-quality products while maintaining regulatory compliance. This guide breaks down key CQV definitions, processes, and regulations for pharmaceutical and life science companies.
Summary
CQV Defined: Commissioning, Qualification, and Validation (CQV) ensure that equipment, systems, and processes operate correctly, consistently, and in compliance with regulatory standards.
Why It Matters: CQV protects patients, ensures regulatory compliance, and enables high-quality, reproducible manufacturing in pharma, 503B, and cell & gene therapy labs.
Core Steps: Commissioning verifies installation and functionality, Qualification confirms performance under operating conditions, and Validation demonstrates processes consistently produce products meeting quality requirements.
Getting Started: Begin with facility and process assessment, develop a structured CQV plan, execute commissioning and qualification, validate processes, and maintain documentation over time.
Strategic Approach: Risk-based CQV and fractional leadership provide senior expertise when needed, optimize resources, and support efficient, defensible, and inspection-ready operations.
In pharma and life sciences, few processes are as critical as CQV. Whether you’re launching a 503B facility, moving into regulated manufacturing as a cell and gene therapy lab, or scaling and modifying operations, the stakes are high.
In highly regulated manufacturing, facility completion is a milestone that matters only if it’s paralleled by operational readiness. And without proper commissioning and qualification in place, you simply can’t produce.
Until systems are rigorously commissioned, qualified, and validated, they aren’t truly ready for patients or regulators.
CQV ensures your systems and equipment operate correctly and consistently. This assures both product safety and regulatory compliance. CQV is a multi-step process that tests your equipment, utilities, lab instruments, and computer systems against industry standards, regulations and requirements. It’s integral to your operations, requires deep expertise, and should be strategically approached.
At Restore Health Consulting, we support facilities with risk-based, inspection-defensible CQV strategies that align with FDA and state expectations while avoiding unnecessary validation burden. Our approach integrates facility design, equipment qualification, process risk, and lifecycle management—not just protocol execution.
In this blog, we’ll break down what CQV is, why it matters, how to get started, and how CQV is applied to pharma and life sciences industries—with a special focus on the personalized medicine industry.
What is CQV?
CQV stands for Commissioning, Qualification, and Validation. It is an important process in the pharmaceutical and life sciences industry that ensures manufacturing processes, facilities, and equipment are functioning correctly.
Although interconnected, each aspect of CQV refers to specific processes and regulations:
Commissioning: verifies and documents that systems, equipment, and utilities are installed and functioning correctly.
Qualification: provides documented evidence that all aspects of a facility, utility, or equipment that can affect product quality perform as intended and specified in the actual operating environment.
Validation: documents and demonstrates that processes consistently and reproducibly produce products meeting quality standards.
While commissioning focuses on systems and equipment, qualification and validation focus on product quality. Together, they ensure that your products are of high quality and meet the necessary regulatory standards.
Commissioning
What it is: An engineering-led verification activity that confirms systems, equipment, and utilities are installed correctly and function as intended.
Goal: Verify that systems and equipment are installed and functioning according to design specifications before GMP qualification begins.
Focus: Engineering functionality, system readiness, and technical performance.
Regulatory Requirements: Commissioning is not typically prescribed as a formal regulatory requirement, but documented commissioning activities are commonly expected and may be leveraged to support qualification and inspection readiness.
Answers: Was it built, installed, and functioning correctly?
Costs: Dependent on facility complexity and project scope, and largely driven by design decisions made earlier in the project lifecycle.
Commissioning includes the following steps:
Planning and preparation
Equipment and system installation verification
Infrastructure and utility verification
Functional testing
Handover to operations
Continued monitoring and optimization
Examples:
Checking HVAC systems operate as designed
Verifying piping connections and electrical wiring
Verifying temperature and humidity control functionality
Confirming equipment starts up and runs properly
Confirming cryogenic storage units, ultra-low freezers, and liquid nitrogen systems are installed correctly and operating within defined parameters
Testing biosafety cabinets, isolators, and laminar airflow hoods to ensure proper installation and functional performance
Commissioning is often performed by engineering teams and provides the foundation for subsequent qualification and validation activities.
Qualification
What it is: A regulated and documented verification activity that confirms equipment, systems, instruments, and utilities perform as intended in the actual operating environment.
Goal: Provide documented evidence that equipment and systems consistently operate within defined limits and are suitable for their intended use.
Focus: Equipment, systems, instruments, and utilities that have a direct or indirect impact on product quality, patient safety, and regulatory compliance.
Regulatory Requirements: Required under applicable FDA CGMP regulations (e.g., FDA 21 CFR Parts 210 and 211) and supported by international quality frameworks such as ICH Q8–Q10. Qualification activities are commonly executed using IQ, OQ, and PQ or equivalent risk-based verification approaches, with documented results available for inspection.
Answers: Will the system operate reliably and consistently within defined operating ranges under real-world operating conditions?
Qualification includes the following steps:
URS (User Requirement Specification)
DQ (Design Qualification)
IQ (Installation Qualification)
OQ (Operational Qualification)
PQ (Performance Qualification)
FAT/SAT (Factory/Site Acceptance Testing)
Example: Running defined test conditions or representative batches to verify outputs meet predetermined specifications.
While commissioning can apply broadly across facility systems, qualification is focused on critical systems (e.g., critical equipment, systems, instruments, and utilities) that can impact product quality or patient safety. These systems are a primary area of focus during regulatory inspections.
Validation
What it is: A regulated and documented process that demonstrates a process, method, or system consistently and reproducibly produces results meeting predefined quality requirements.
Goal: Demonstrate that products and processes are fit for their intended use and consistently meet predefined safety and quality attributes.
Focus: Manufacturing processes, analytical methods, cleaning processes, and computerized systems that directly or indirectly impact product quality and patient safety.
Regulatory Requirements: Validation is required under FDA CGMP regulations (including 21 CFR Part 211 and Part 11 where applicable) and aligned with industry standards and guidance such as FDA Process Validation Guidance, ICH Q7–Q10, and applicable USP and ISO standards. Validation activities must follow approved protocols, predefined acceptance criteria, and generate documented evidence suitable for regulatory inspection.
Answers: Does the process consistently produce products that meet quality and safety requirements?
Examples:
Process Validation
Analytical Method Validation
Computer System Validation
Within the pharmaceutical / biotech industries, validation is an overarching element of a pharmaceutical quality system that includes qualification as part of the overall lifecycle approach.
To ensure that the products are fit for intended use, the organization must demonstrate in a documented form that the processes, methods, tests, controls, and equipment they deploy are capable of repeatedly producing the desired outcome.
Why CQV Matters
In pharma, 503B compounding, and cell & gene therapy, advanced equipment and facilities are only part of the equation. CQV turns intent into proof, confirming that systems and processes are reliable, reproducible, and inspection-ready. It bridges technical setup and real-world performance, helping ensure complex systems deliver safe, consistent results.
CQV matters because it:
Protects patients and product quality: By documenting that equipment, systems, and processes perform as intended, CQV helps ensure products meet specifications before they ever reach patients.
Supports regulatory compliance: Regulators don’t just check what works, they check what’s documented and justified. CQV provides a clear audit trail, demonstrating alignment with FDA, EMA, and other global GMP expectations.
Strengthens quality assurance: CQV confirms critical systems and processes are capable of operating within defined limits, supporting consistent manufacturing and long-term product integrity.
Enables faster, more confident scale-up: In high-complexity settings like cell and gene therapy labs, CQV prevents costly surprises by identifying gaps before full-scale production, helping teams move confidently, reducing delays, rework, and unexpected compliance gaps.
Drives operational efficiency: Systems that are commissioned, qualified, and validated are easier to maintain, troubleshoot, and optimize. CQV ensures equipment operates within specified parameters, minimizing downtime, deviation, reducing unnecessary waste, and optimizing production output.
Implementing a rigorous CQV process embeds quality into the fabric of your operations. For CGT and 503B facilities, where product sensitivity and small batch sizes leave no room for error, CQV directly supports safe, efficient, and compliant manufacturing.
How to Get Started with CQV
Implementing a robust CQV program doesn’t have to be overwhelming. Whether you’re building a new facility, upgrading equipment, or scaling cell & gene therapy operations, a structured approach supports efficiency, compliance, and risk reduction.
1. Planning and Assessing Your Facility and Processes
The first step to getting started is planning and assessing your current processes and facility.
Start by evaluating your current operations, facility design, and equipment. Identify which systems are critical to product quality, patient safety, and regulatory compliance. This assessment helps prioritize where CQV efforts will have the greatest impact.
You need to develop a comprehensive CQV plan outlining the scope, systems and processes, goals, timelines, regulatory requirements, and industry best practices.
2. Build Your CQV Team
The second step is to build your CQV team. Many companies debate between hiring in-house validation personnel or engaging third-party consultants or service providers for these tasks. While both approaches have merits, outsourcing validation activities to specialized consultants frequently emerges as a more cost-effective and efficient solution.
3. Develop a CQV Strategy and Plan
Define the scope, objectives, timelines, and responsibilities for commissioning, qualification, and validation. Decide which systems require full IQ/OQ/PQ protocols, which can follow a risk-based approach, and how documentation will be managed.
The typical documentation lifecycle supporting GMP qualification and validation includes the following five steps:
Validation master plan
Validation protocol
Execution of qualification and validation activities
Validation report
Preparation of SOPs
These steps are key to preparation, documentation, and implementation of GMP validation for regulatory compliance.The validation master plan is the roadmap for your CQV implementation, providing an overview of your company’s validation strategy.
4. Execute Commissioning Activities
Before formal qualification, verify that equipment, utilities, and facility systems are installed correctly and operate as intended. Examples include testing HVAC airflow, validating clean gas supply, and confirming cryogenic storage functionality.
5. Conduct Qualification
Follow documented protocols (IQ, OQ, PQ) to demonstrate that systems and equipment perform consistently under operating conditions. Capture results, address deviations, and compile final reports for regulatory review.
6. Validate Processes
Focus on the procedures and manufacturing processes that directly impact product quality and patient safety. Validation ensures that processes consistently deliver the intended results, from aseptic operations to cell therapy production.
7. Maintain and Update CQV Documentation
CQV is not a one-time effort. As facilities, equipment, or processes change, update qualifications and revalidate impacted systems as required to maintain regulatory compliance. Keeping documentation current ensures continued compliance, continued process verification, and inspection readiness.
The Bottom Line
Getting started with CQV early reduces risk, prevents costly delays, and ensures patient safety from day one. Ideally, you should start thinking about CQV during facility design or before first GMP manufacturing.
CQV for Pharma and Life Science Industries
CQV in the life science and pharmaceutical industries defines a detailed and science-based process for the specification, design, and verification of new equipment or systems into a production pipeline.
Whether you’re launching a new product, modifying an existing product, or scaling your facilities and equipment, CQV is integral. CQV practices are informed by several industry/regulatory guidelines including:
ISPE Baseline Guide 5 “Commissioning and Qualification (Second Edition)
ICH Q8 (Pharmaceutical Development), ICH Q9 (Quality Risk Management), and ICH Q10 (Pharmaceutical Quality System)
Cell & Gene Therapy Labs Quality Control & CQV
Cell and gene therapy (CGT) labs operate at the forefront of medicine, which makes quality control and CQV essential.
These facilities must comply with regulatory frameworks including FDA cGMP requirements, USP standards where applicable to sterile handling and testing, and international guidance such as EU GMP and ISO cleanroom standards. Therapies must be thoroughly tested after being manufactured and over time to confirm that they continue to be effective throughout the intended shelf life.
While the details vary, the goal is consistent: products must meet a set of pre-defined quality standards and be safe and effective for patients.
CQV, QC, and QA
Because CGT products are often living cells or viral vectors with short shelf lives, CQV must appropriately focus on sterility, traceability, and rapid, often automated, processing.
Strict regulatory-compliant quality control (QC) and quality assurance (QA) measures are needed to ensure the safety and efficacy of these therapeutics throughout their lifecycle, from initial raw material collection and equipment validation to patient administration.
Regulatory Guidelines
Due to the complexity of CGT products, regulatory agencies like the FDA enforce strict guidelines to safeguard their quality, safety, and efficacy through current good manufacturing practices (cGMP). In some cases, nonclinical studies supporting development may also be subject to good laboratory practices (GLP).
cGMP governs manufacturing. The FDA's 21 CFR Parts 210 and 211 establish the core cGMP framework for manufacturing, with additional regulatory considerations applicable depending on CGT product classification.
GLP defines requirements for nonclinical laboratory studies supporting development, including data integrity and assay reliability. The FDA's GLP standards are detailed in 21 CFR Part 58.
Although harmonization efforts are underway, CGT quality testing varies by region and product type. Organizations like the FDA, EMA, and ICH continue to push for standardization.
FDA published a guideline specific to Chemistry, Manufacturing, and Control (CMC) programs for CGT at the Investigational New Drug Applications (IND) stage that outlines critical areas.
Unique Challenges
Cell therapy products need the full range of safety, environmental, and cellular quality attribute (CQA) tests. Contamination is a constant threat in cell and gene therapy manufacturing, making aseptic control critical. Safety testing includes sterility, mycoplasma testing and endotoxin testing to ensure a product is not contaminated. CQA testing, including identity, viability and potency tests are also crucial as they help ensure that patients are getting dosed correctly.
Since cell and gene therapies are likely to be manufactured in small batch sizes and have strict time restraints, quality control is more challenging than with traditional biopharmaceuticals. Innovative approaches are constantly looking for ways to create faster and more appropriate novel testing methods for these therapies.
Developing a control strategy for CGT products requires substantial scientific, technical, GMP quality system knowledge and experience.
In addition, cell and gene therapy labs face significant staffing challenges. Many small CGT labs have small, highly specialized and knowledgeable teams working around the clock. Adding another full-time quality or CQV expert can be expensive and unrealistic, yet quality control is integral to manufacturing and scaling. In such cases, a fractional CQV leader can bring the needed senior-level expertise without long-term overhead—especially during early stages or high turnover periods.
For CGT teams looking to structure their operations and ensure regulatory readiness, fractional CQV leadership or a tailored CQV program can provide both compliance and operational confidence. Schedule a call to explore how Restore Health Consulting can support your CGT lab.
CQV for 503B Outsourcing Facilities
For 503B outsourcing facilities, adhering to Good Manufacturing Practice (GMP) standards is essential to ensure product quality and regulatory compliance. A critical component of GMP is the qualification of facilities and equipment and the validation of manufacturing processes, which together confirm that products are consistently produced to meet predetermined quality criteria.
As outlined in FDA Current Good Manufacturing Practice—Guidance for the 503B Industry,
Part 211 sets out the requirements applicable to the design of facilities used in the manufacture, processing, packing, or holding of a drug product (see, e.g., § 211.42). The design of a facility should consider the products produced and must provide the necessary level of control to prevent mix-ups and contamination (§ 211.42).
The Value of Risk-Based CQV
While CQV remains fundamental to 503Bs, many CQV programs still default to the assumption that more testing means lower regulatory risk. This leads to validation programs that are resource-heavy but strategically weak. Teams spend months validating low-impact parameters while genuinely critical risks remain poorly justified.
The costliest validation programs are often the least strategic. That’s because they fail to pinpoint what actually matters and why, driving up costs and leaving you with a large validation package that’s difficult to defend during an FDA inspection.
CQV strategy shouldn’t be about doing more validation, it should be about doing validation strategically. In 503B outsourcing facilities, defensible CQV programs are built on formal risk assessments.
A well-executed risk assessment:
Defines what truly matters to product quality and patient safety
Justifies why certain parameters are validated and others are not
Allows for legitimate bracketing, matrixing, and reduced testing—without increasing FDA risk
When validation is risk-based and documented properly, it becomes easier to defend during FDA inspection, easier to maintain over time, and less expensive because scope is right sized up front.
To learn more about CQV in 503Bs, read this article: 503B Outsourcing Facility Start-Ups – Commissioning, Qualification, and Validation
CQV Personnel Challenges & Fractional CQV Advantages
Whether you’re running a compounding facility, pharmaceutical manufacturing, or a cell and gene therapy lab, deciding how to approach CQV staffing can make a key difference.
In reality, most facilities don’t need a full-time validation FTE. They need validation leadership at the right times. This challenge is especially common in growing 503B outsourcing facilities and CGT labs, where validation needs are episodic but inspection expectations are continuous.
Employing full-time validation staff comes with ongoing costs for salaries, benefits, training, and overhead. Since validation activities are often periodic, full-time employees may be underutilized. Engaging third-party consultants on an as-needed basis can be more cost-effective, despite higher hourly rates.
For example, in 503B facilities, validation work doesn’t happen evenly. It happens in bursts:
Initial qualification
Periodic requalification
Expansion or remediation
Between those bursts, there often isn’t enough day-to-day CQV work to justify a full FTE. So validation roles can get diluted into QA, projects, or operational support. Over time, this can lead to inconsistent decision-making, over- or under-validation, and weaker justifications during regulatory inspections.
A fractional CQV leader provides:
Senior-level validation decision-making
Oversight of third-party validators
Defensible scientific rationale
Cost control without sacrificing expertise
In practice, this means better validation decisions, stronger inspection defenses, and lower total CQV cost over time. GMP validation consultants bring specialized experience across diverse clients and systems. Their hands-on work writing protocols and executing validation keeps them current with regulatory requirements and industry best practices, allowing them to design and implement validation processes efficiently and effectively. Outsourcing validation services also provides companies with the flexibility to scale resources up or down based on project demands.
You get:
The right experience
When you actually need it
Without carrying long-term overhead
Engaging experienced GMP validation consultants not only ensures compliance and mitigates risks but also provides operational flexibility and access to the latest industry best practices, ultimately supporting the company's commitment to quality and regulatory adherence.
For many facilities, this isn’t a compromise. It’s a smarter model.
Read more here: Which Makes More Sense - Employ GMP Validation Personnel or Engage a Third-Party?
Want to sanity-check whether a fractional CQV model would reduce risk or cost in your current operation?
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