Glossary Definition: Quality Control (QC)

Quality control (QC) is a division of a pharmaceutical company that is legally responsible for ensuring that their company complies with regulatory requirements. In essence, QC teams deliver on the promise that products will work as intended by confirming that the products are safe, effective, and error-free, prior to reaching consumers.

In manufacturing, quality assurance (QA) and quality control both play a key role. Although these terms may sometimes be used interchangeably, they serve two very different functions:

• QA relates to how product quality is managed throughout production, and is handled through validation and qualification of the process
• In contrast, QC refers specifically to the legal compliance of the product, by conducting tests that are in compliance with the law

Neither process can replace the other, and both QA and QC are necessary prior to commercializing a new or existing product.

Quality Control can go by several other names, including:

• Quality check
• Quality verification
• Cross-check 
• Process control

In pharma, quality control refers to the process of testing drug materials, environment, production, and release to validate their quality standards. Once verification happens, these elements can be used in the manufacturing process. The QC process varies by therapy, as each drug adheres to its own set of specifications and regulations.

QC activities include, but aren’t limited to:

• Sampling
• Stability testing
• Testing against specifications
• Testing packaging materials
• Investigative testing

Drug manufacturers follow QC guidelines to ensure products are safe and free from defects prior to commercialization. Additionally, Good Laboratory Practices (GLP) — which pharma companies abide by — incorporate quality control measures. Together, these help to ensure drug efficacy, consistency, and safety.

Quality control is important in pharma because when patients receive drugs, they expect them to be safe, effective, and able to deliver on their promised benefits.

In the absence of QC, drug development and manufacturing would be unable to legally operate. In addition, potentially dangerous medications could enter the market, resulting in serious implications. As such, QC protects both consumers and manufacturers by controlling product quality throughout every step of the manufacturing journey.

QC procedures benefit consumers and companies alike because they protect product integrity, ensure organizations are compliant with regulatory bodies throughout production, and guarantee products are safe and effective.