By: Eric Watkins

Validation of laboratory equipment is a continuous process of verifying that the systems are adequate for their intended use both initially and over time. Validation is time consuming, difficult, and costly, but must be executed to verify that the systems are adequate for use and are working according to user requirement specifications. Equipment and method validation ensure that equipment and processes comply with regulatory bodies, reducing risk of audit findings, fines, or even closure. Qualification of equipment and processes provide confidence in a company’s process robustness, reducing the risk of process deviations due to equipment and procedures. Validating equipment and processes improves efficiency and quality that ultimately gives the company assurance that the highest quality product, free of adulteration, is
released for use.

Validating Improves The Quality of Products

Validating equipment contributes to the SQuIPP (Safety, Quality, Identity, Potency and Purity) of the final product. By validating lab equipment, you can be certain the equipment and process provide the results as intended every time.

While each drug a patient takes is not tested, it goes through a proven validated process for manufacturing and validating the product. Methods to test batch samples are key to ensure quality products reach each patient.

Validating ensures equipment and methods are accurate and reproduceable. It holds equipment manufacturers and method developers accountable by generating data to prove the equipment and methods do what they are intended to do.

Identify What Equipment Should Be Validated

First, a validation team should be assembled. If there is not a validation team available, then a third party, outside, organization should be utilized. The extent of validation should be determined based on impact to the product. For example, does any part of the method or equipment impact or preserve the safety, quality, identity, potency or purity? Is any part of the system not impacted? Is there indirect impact to any part of the system?

Equipment Qualifications Reduce The Risk of Non-Compliance With Regulatory Bodies

Responsibility for complying with the appropriate industry standards ultimately falls on individual companies, divisions, or departments. Validation gives those responsible the documented evidence they need to meet regulatory requirements.

FDA and other regulatory bodies require that equipment, especially laboratory equipment, utilized in testing of finished product produced by pharmaceutical and other manufacturing facilities have documented executed qualifications showing reproducible results. It is a documented process providing proof that the equipment is installed, operates, and produces repeatable results in the testing process. It essentially proves that the testing process is in a state of control.

Validation provides the link between requirements, design, system functionality, and process effectiveness.

Validating Equipment Is Ultimately a Cost Saving Improvement

Equipment validations can decrease essential in-process controls and testing. They give the end user proof that testing results are valid which can provide peace of mind that, in certain cases, a recall of product is not needed.

Failure to comply with current good manufacturing practices (cGMPs) or good laboratory practices (GLPs) can have serious consequences, including regulatory restrictions such as the inability to sell the product. Recalls are costly in and of themselves, and the potential damage in consumer confidence in the product, brand, and company can be immeasurable.

How Equipment Validations Improve Process & Procedural Robustness

A documented qualification leads to improvements in procedural processes by providing a template for robust procedures and processes. Validation provides a baseline of documented data/objective evidence at the start of an equipment lifecycle and at any point change is introduced.

Validation is a standardized process of proving equipment and method efficacy which can be audited by regulatory authorities to ensure all products to market are being produced and tested at a certain standard.