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A single day of production delay in pharmaceutical manufacturing can cost a company $1 million or more in lost revenue. When commissioning, qualification, and validation (CQV) activities get compressed at the end of a project schedule, minor issues can quickly escalate into significant delays, costly change orders, and strained relationships between project teams.

Despite its critical importance to operational readiness, CQV is often treated as an afterthought rather than an integral project requirement. This creates tension between schedule timelines and regulatory compliance, leading to a “CQV crunch” where testing is rushed. This article examines the challenges of enhanced commissioning and pharmaceutical validation integration and explores strategic approaches that can transform CQV from a schedule constraint into a project enabler that protects both timelines and compliance.

Current challenges in pharmaceutical validation

Pharmaceutical manufacturing validation has evolved significantly over the past decade, with regulatory bodies placing increased emphasis on quality management systems and risk-based validation processes. Yet many organizations still struggle to integrate CQV activities effectively into their project timelines. This misunderstanding often stems from varying levels of GMP maturity—while established pharmaceutical companies may understand validation requirements intimately, organizations newer to regulated manufacturing frequently underestimate the complexity and time required for proper validation.

When CQV teams join a project late, they often encounter a cascade of challenges:

• Systems already installed but not designed for GMP compliance
• Documentation gaps in construction verification and testing
• Critical inputs from operations are not yet available

These challenges force validation specialists into a reactive rather than proactive stance. They must now scramble to identify and rectify issues that could have been prevented with early involvement. The compressed schedule typically leads to validation activities being executed in parallel rather than sequentially, increasing complexity and or misalignment.

For facilities producing high-value biologics or specialized pharmaceuticals, even a week’s delay in operational readiness can translate to millions in lost revenue—revenue the company can never recover. With corporate leadership focused on specific operational dates, the pressure to compress validation timelines can increase if there are construction or equipment delivery delays. These conditions produce a cycle in which arbitrary deadlines may compromise quality and compliance.

Additionally, the current trend toward onshoring and transferring processes back to the US, driven by tariffs and regulatory challenges, is creating even greater urgency around efficient CQV implementation. As companies establish new domestic facilities and retrofit existing ones, CQV becomes vital for achieving GMP compliance quickly and accelerating FDA approval in these time-constrained scenarios.

Key strategies for effective CQV integration

Whether you are managing a greenfield pharmaceutical construction project or retrofitting an existing production space, the path to successful commissioning and validation requires strategic planning and cross-functional collaboration. The following approaches can help organizations avoid the end-of-schedule crunch and ensure CQV activities support rather than hinder project timelines.

Early integration: beginning with the end in mind

The single best strategy for avoiding delays to operational readiness is to involve CQV specialists during the project’s definition phase. This early engagement allows commissioning and validation input into design requirements from the outset rather than forcing systems to be modified later. During this phase, CQV experts can help project teams develop comprehensive user requirements, documenting the basic acceptance criteria for testing ability.

A common misconception is that early CQV involvement requires a full validation team from day one. Bringing in a senior CQV resource on a part-time basis during detailed design and equipment specification can yield significant benefits with minimal budget impact. This expert can take part in design reviews, develop equipment specifications, identify potential validation challenges, and help establish realistic milestones in the master schedule that account for commissioning and qualification activities.

During these early stages, a senior CQV resource can also begin developing the Commissioning and Validation Master Plan, which outlines the approach, policies, and required deliverables. Taking this step helps keep stakeholders aligned before construction begins.

Building bridges between construction and validation

One persistent challenge in pharmaceutical projects is the relationship between construction teams and CQV specialists. Construction teams frequently perceive validation as a process designed to identify flaws in their work, while validation specialists may feel that construction priorities overshadow critical quality requirements.

Breaking down these silos starts with establishing clear communication channels and sharing accountability. Regular cross-functional meetings help each group understand the other’s priorities and constraints. Additionally, they allow potential issues to be identified and addressed before they impact the schedule.

Documented construction field tests provide another opportunity for collaboration. When CQV teams review and provide input on construction field forms early in the project, they can verify that these documents capture the information needed for validation, preventing redundant testing later. This proactive approach saves time and reduces the burden on construction teams by eliminating the need to reproduce documentation in different formats.

The master schedule should identify clear mechanical/electrical completion dates for critical systems like HVAC, process utilities, and equipment. These milestones create natural handoff points between construction and the CQV teams, preventing them from waiting idly for systems to become available for testing.

Smart documentation management systems

The volume of documentation required for pharmaceutical CQV is staggering. Without proper systems in place, managing this documentation becomes a significant bottleneck that can delay operational readiness even when physical systems are complete and functioning correctly.

Implementing a centralized approach to documentation management from the outset pays dividends throughout the project lifecycle. For enhanced commissioning turnover packages (ETOPs), establishing a receiving and tracking system early prevents the common scenario of countless pages of documents being delivered at project completion without organization or indexing.

Drawing management presents another documentation challenge. During construction, it is typical for multiple stakeholders to maintain their own sets of drawings with markups and revisions that may conflict. Implementing a centralized drawing management process delivers consistency and reduces the time required for a review of the final as-built documentation..

Punch list management systems established for commissioning provide a structured approach to tracking and resolving deficiencies identified during commissioning verifications. By categorizing issues based on safety, cGMP impact, and owner preference, these systems help teams prioritize their efforts and focus on resolving issues that directly affect the CQV timeline.

Risk-based approaches to compressed schedules

Despite best efforts at planning, many pharmaceutical projects face schedule compression because of construction delays, equipment delivery issues, or changes in project scope. When time gets constrained, a risk-based approach to validation helps teams focus their efforts where they matter most.

This approach begins with identifying critical systems that directly impact product quality and patient safety. For a sterile injectable facility, this might include classified clean rooms, water for injection systems, and sterilization equipment. Prioritizing the validation of these systems addresses the most significant compliance risks, even with compressed timelines.

Parallel path or phased construction and CQV activities can help recover the schedule without compromising quality. With formal construction segregation planning CQV activities can begin in mechanically complete areas or finished spaces while construction continues in other areas helping compress the overall project timeline.

For retrofit (“brownfield”) projects where production must continue in adjacent areas, construction segregation strategies become essential. These include establishing containment barriers, implementing protocols for worker movement, and conducting environmental monitoring to verify effectiveness. These measures allow CQV activities to proceed in parallel with ongoing production, preventing extended facility shutdowns.

How Salas O’Brien can help

We specialize in CQV and can help with your next project in several ways:

• Integrated engineering and validation expertise. The advantage of working with Salas O’Brien lies in our unique combination of engineering knowledge and CQV validation experience. Unlike “validation-only” firms, we understand the technical details of the systems we validate, allowing us to identify practical solutions that meet both operational needs and regulatory requirements. This integrated approach prevents the common disconnect between design intentions and validation execution that often leads to schedule delays.
• Early CQV involvement that maintains independence. While our validation team works closely with our engineering groups, we maintain the appropriate organizational independence required for objective assessment. Our validation specialists follow a separate reporting structure from design teams, allowing them to evaluate systems without bias while still leveraging the organization’s collective knowledge. By balancing collaboration and independence, we help clients navigate the challenges of CQV without sacrificing quality or compliance.
• Experience across diverse pharmaceutical environments. From small-scale retrofits to complex greenfield projects, our validation team has experience across the spectrum of pharmaceutical manufacturing and packaging environments. Whether you’re producing oral solid dosage, suspensions, small-molecule pharmaceuticals, biologics, gene therapies, or medical devices, we understand your process’s unique validation requirements and can tailor our approach accordingly.
• Strategic partnership for operational readiness. By partnering with Salas O’Brien for CQV services, you gain more than just validation support—you gain a strategic ally focused on helping you achieve operational readiness as efficiently as possible. We understand that CQV is ultimately about enabling safe, compliant production, and we work tirelessly to help our clients reach that goal while limiting unnecessary delays or complications.
• Specialized approaches for compressed schedules. When time is not on your side, having the right CQV validation partner becomes even more critical. Salas O’Brien’s CQV team specializes in developing efficient strategies that prioritize critical systems, optimize testing approaches, and assist with documentation quality. These strategies help you navigate the CQV crunch without compromising compliance or safety.

Getting CQV right the first time is always more efficient than rushing to fix issues later. Partnering with experts who understand both the engineering and compliance aspects of pharmaceutical manufacturing is the most reliable path to operational readiness without costly delays.

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