The Difference Between Validation and Strategic Revalidation

In the area of GxP compliance, there are two main types of process validation that ensure continued quality.

1. Initial Validation occurs when systems are commissioned or new procedures are introduced. 

2. Revalidation is based on several factors, including regulatory compliance and regulations, changes/modifications in systems or procedures, reconfiguring of warehouses, changes in raw materials, equipment, software, support systems, or even a non-compliance event.

Revalidation can also be performed periodically to ensure that the process remains in a state of control, even in the absence of changes.

Beyond the Invoice

In all these cases, delays in execution can have far-reaching implications for product integrity, patient safety, data integrity, and inspection readiness. 

As a result, the overall cost moves beyond revalidation itself; it is the fallout and real costs that impact the operating plan, financial plan, patient impact, and the company’s reputation in the event of major delays.

Depending on the severity of the event, these costs beyond the invoice can be monumental.

• Unexpected operational costs specific to the revalidation, including labor, testing materials, and potential external contractors

• Idle infrastructure, including equipment downtime, lost throughput, and delayed product release

• Opportunity costs, including postponed sales campaigns, lost market confidence, and revenue

• Regulatory risk with compliance exposure/risk to GxP status/data gaps/increased revalidation cycling

In the longer term, other issues could impact the organization. These include patient outcomes, gaps in commercial supply, and delayed clinical timelines.

Looking at the bigger picture, the real cost is not the unplanned validation; it is the disruption caused by delays in revalidation and regular risk-based assessments. Ideally, risk assessments should be planned and carried out at scheduled intervals to identify potential problems associated with the processes, systems, and equipment. This is critical in preventing issues that could compromise the quality of the products or the compliance of the process, and identify the strategic validation approach going forward.

Moving to a Validation Master Plan

Organizations that treat revalidation as a strategy outperform those that treat it as a compliance hiccup. These strategic organizations generally engage in and create a Validation Master Plan (VMP).

Like any plan, be it operational, financial, or otherwise, the VMP is integrated into the overall strategy of the organization to ensure continuity and GxP compliance. Quality-driven organizations combine this with overall scope and objectives. Risk management plays a key role in planning while considering change control and quality management by utilizing risk-based decision making and planned revalidation scheduling.

Bridging Quality and Business Operations

If we look at this from an overall business operations point of view, the Validation Master Plan can be incorporated into the Sales and Operations Planning (S&OP) process. This is a well-disciplined balancing of supply/demand/finance; it is the single operating plan of the organization.  Incorporating a quest for excellence balances safety, quality, and throughput. It’s all about focus, applying best practices to optimize supply with financial considerations while meeting demand. 

This coordinated approach helps pharmaceutical organizations work smarter and more effectively. It improves efficiency through risk-based planning, mitigating unplanned events, and saving time and resources. It supports compliance by ensuring ongoing alignment with GxP requirements, with a focus on regular quality reviews. Quality and safety ensure reliable throughput and patient safety.

Overall, this creates an agile organization, shifting the focus from reactive behavior to building in a quality focus from the start, creating a more reliable operation.