Emma Radebaugh
The modern-day pharmaceutical industry is a rapidly evolving environment due to demands for efficiency, globalized regulation developments, and product and supply chain complexities. What hasn’t changed is the ever-present need for quality, efficacy, and safety for comprehensive consumer health.
Quality management in the pharmaceutical market relies heavily on the terms of Quality Assurance (QA) and Quality Control (QC). Both quality assurance and quality control play an integral role in the manufacturing of APIs and manufactured medicines. People often utilize these operational terms interchangeably, but they are not one and the same in context. To aid understanding, let’s examine the difference between QA and QC in pharmaceuticals. Here’s what you need to know about these related roles.
Assurance: Quality in Production Processes
Quality assurance is essentially a process-oriented approach to manufacturing standards. Ergo, this concept critically aims to prevent defects through refining production processes. Covering all facets that could impact the quality of prescribed pharmaceutical products, this portion of quality management focuses on providing confidence in fulfilling high-standard requirements.
Within the industry, QA has the final say over raw material quality and batch quality. They also oversee FDA inspections and customer audits. QA utilizes Pharmaceutical Quality Systems to document and manage the quality of a product for consumer needs. Patients can’t see quality but always expect quality performance and satisfaction during use.
Control: Quality in Raw Materials and Products
Conversely, quality control is essentially a product-oriented approach to manufacturing standards. QC assesses chemical, physical, and biological components, including the raw materials that comprise the product as well as the manufactured product itself. This group customarily analyzes chemical batches, tests samples, and compiles performance data to detect substance faults or quality lacks.
QC is a corrective tool analyzing the validation of outputs, executing tests on process methods, and producing stability through specification studies. These processes must align with regulatory GLP requirements to ensure purity standards in pharmaceutical ingredients.
Rendered Quality: The Result of Intention
The difference between QA and QC in pharmaceuticals is not always clear-cut, as the lines of responsibility in quality management can blur. Regardless, the comprehensive goal is to manufacture and deliver zero-defect pharmaceutical products to patients on a consistent basis. As a measure of excellence, quality is always the result of refined intention from manufacturing techniques and systems. By collectively working together and placing a relentless focus on quality, organizations can meet current Good Manufacturing Practices (GMP) standards to produce business success and better patient outcomes.
