What Does a Validation Expert Do and Why Do I Need One?

As you’d expect, a validation expert’s work includes preparing and executing a range of protocols, such as installation qualification (IQ), operational qualification (OQ), performance qualification (PQ), analytical method validation (AMV), cleaning validation (CV), process validation (PV), computer system validation (CSV), etc. 

But these protocols are just the means to an end: preventing situations that may lead to your drug products being deemed adulterated. No one wants to read “drug deemed adulterated” in an FDA 483 letter. How can that happen? It’s spelled out in Section 501 (a)(2)(B) of the Federal Food, Drug and Cosmetics Act: 

[A] drug is deemed to be adulterated if the methods used in, or the facilities or controls used for its manufacture, processing, packing, or holding do not conform to or are not operated or administered in conformity with the Current Good Manufacturing Practices (CGMPs). This definition establishes links to most of the systems that require validation: equipment, utilities, facilities, materials, analytical methods, manufacturing processes, cleaning processes, computer systems, etc. And testing these systems, sites, and methods requires you—or your validation expert—to generate documentary evidence that they consistently and reliably perform as intended and that cGMPs are followed throughout the product’s lifecycle. The ultimate goal of all validation activities is to ensure drug products have the strength, identity, safety, purity, and quality (SISPQ) that the law requires. 

Although validation is a regulatory requirement, the FDA only outlines how to perform it. There is no clear description of the specifics or the extent of the validation activities the FDA expects companies to perform. That raises the risk of doing too much or too little, especially if you’re new to validation. Someone with validation expertise, however, can tell you what to validate, to what extent, and how much documentation to generate. 

To start, a validation expert relies on a risk- and science-based rationale to formulate the validation strategy and to tailor the plan to your company’s specific needs. Avoid using a one-size-fits-all approach as a shortcut. That can lead to major compliance issues and technical failures. It’s better to spend the time and money to develop a scientifically sound validation approach. That investment will pay big dividends in terms of meeting regulators’ expectations and operating a better business, because it optimizes use of your equipment, materials, utilities, facilities, processes, etc. When performed on a scientific basis, validation can offer a tremendous reduction in process failures, product rework, rejects, recalls, and lawsuits. That means a more profitable operation. 

A true validation expert uses a validation master plan (VMP) to develop and document a validation strategy that ensures GMP compliance throughout a product’s lifecycle. A well-developed, clear, and concise VMP goes a long way toward clarifying and defending your validation approach when customers or regulators perform quality audits. 

But we shouldn’t become complacent thereafter. Even when operations start with adequate validation, unintended and unexpected changes may creep into the systems. This can happen despite having the mandatory change-management system in place, and it can degrade the state of control over time. A validation expert can help you return operations to a state of control by performing a validation-gap analysis—delineating “as-it-is” versus “as-required”—and by developing and implementing remedial actions. 

At every step, the recommendations must be practicable, economical, and sustainable. The life sciences industry needs a validation expert not only to achieve compliance with FDA regulations, but also to gain a technical and business lead over competitors. With the FDA’s everincreasing emphasis on Quality by Design (QbD) and on using a riskand science-based approach, the role of validation experts has gained significance. By helping you meet the expectations of today’s regulators, a validation expert can help your company design and build quality, safety, and efficacy into products. It’s shortsighted to rely only on testing the finished product. 

Again, invest wisely to realize the best returns. Don’t rely on cookiecutter validation protocols. They might patch you up, but they won’t help you accomplish your long-term goals in regulatory compliance or business competitiveness.