Glossary Definition: Quality Assurance (QA)

Quality assurance (QA) is a validation process put in place to objectively evaluate a product or process against applicable standards, procedures, and expected results. The goal of QA is to ensure products and services meet stringent quality standards to ensure product safety and efficacy for the consumer. To accomplish this, QA teams seek to identify, document, and resolve deviations from expected results to ensure quality throughout the manufacturing lifecycle.

Although all consumer-facing industries rely on QA to a certain extent, the specific processes and regulations vary. For example, in retail customer service, QA may encompass the various protocols agents must follow when speaking to customers. This process may include a checklist, scripts to follow, etc. QA serves as an instruction manual for how to perform a specific process with consistently, acceptable and expected results. For the retail example above, this would include guidance on customer-agent interaction and the desired experience or outcome of the consumer.

In contrast, QA in manufacturing relates specifically to how a product is made. The guidelines professionals follow in manufacturing are highly regulated, and wholly subject to audits. As such, manufacturing companies spend a lot of time managing product quality throughout the production process to ensure the final product meets compliance standards and applicable industry regulations.

In manufacturing, quality assurance and quality control both play a key role. Although these terms are sometimes used interchangeably, they serve different functions:

• QA relates to how product quality is managed throughout production
• QC refers specifically to the inspection process of the product

Neither process can replace the other, and both QA and QC are necessary prior to commercializing a new or existing product. QC is a necessary step in the QA process, and helps to outline acceptable product characteristics and parameters.

QA in pharma refers to a set of processes put in place throughout the drug development lifecycle to ensure the safety, purity, and efficacy of medications.

Not only does QA in pharma protect consumers from purchasing and ingesting potentially harmful substances, but it also guarantees a consistent product is released within required industry regulations and acceptable limits. As part of the QA pharmaceutical process, any adverse event found during manufacturing is investigated prior to release to further secure confidence in the product.

Quality Assurance is important in pharma because it prevents incorrect, unsafe, or contaminated therapies from entering the market. As such, it is a crucial step to ensure customer safety. It also ensures a baseline level of continuous improvement so that nothing falls through the cracks through QA-owned systems such as CAPA.

Think of QA as a “checks and balances” system for the pharmaceutical industry. It involves following detailed instructions to manufacture drugs while adhering to strict regulatory guidelines. Plus, QA requires pharma organizations to record every step along the way — including deviations, processes, and procedures. Furthermore, these records must be written at the time of execution, by the person who performed or verified the step.

QA verifies the purity and efficacy of medication, and creates a paper trail in the event an FDA audit occurs or a company needs to review a specific drug or batch in the future.

In conclusion, quality assurance is a process to evaluate the quality of a product or service and minimize deviation from planned manufacture. It’s essential in all industries that directly or indirectly serve consumers, including retail and manufacturing. QA ensures products, such as drugs, are manufactured in accordance with predetermined regulations, meet predetermined QC criteria and ensures a consistent quality and safety of products for consumers.