What Are FDA Drug Validations?

The Food and Drug Administration offers a drug validation program. This program evaluates manufacturing processes to ensure that all drug and drug-related products will be reliably produced with the same level of quality during each production cycle. This validation is gained through rational experimental design, evaluation of data and a set development and production phases that has been created, reviewed, approved and implemented for the particular drug.

Applications

• FDA drug validation can be conducted for drugs used for humans and animals; synthetic cells and tissues; and commonly used ingredients in medication mixtures. Validation is not available for specially formulated animal feed, implanted medical devices, vitamins, supplements or transplants. Drug validation examines the manufacturing life cycle and the ability of the manufacturing process to ensure quality, safety and efficacy. It does not regulate automated process control systems.

Process Design

• Process design examines the manufacturing process that will be utilized for the product. The goal of this step is to ensure that a plan is in place to consistently deliver the same product. The plan should be developed in accordance with sound scientific methods and principles and should be documented and reviewed internally to preserve the information for future use. The FDA will examine the process to ensure that the drug components are maintained in the specified ratios to obtain the desired results. The equipment will also be inspected to determine if it is capable of manufacturing the product according to the design specifications.

Process Qualification

• The process qualification stage evaluates the facility, equipment and utilities to determine if they function well during production. If acceptable, products manufactured during evaluation can be released. The production process is repeatedly interrupted to determine if the equipment and utilities can handle quick stops and restarts, which may be necessary due to equipment failure, loss of utilities, employee injury or quality control checks. The results of the interruptions are documented, problems are evaluated and solutions are implemented to correct deficiencies. This stage is repeated until the process, equipment and worker components all function properly.

Continued Verfication

• This is the final stage in drug verification, and it verifies that there will be a continued assurance of product quality. This stage includes ongoing efforts to collect and analyze the product at random intervals so that quality can be continually reviewed by the FDA. Drug verification may need to be obtained again if there are complaints, recalls, changes in the manufacturing process or changes in the drug components.