Glossary
Quality Assurance
What is Quality Assurance?
Quality Assurance (QA) is a process that ensures products and services meet established quality standards. It involves activities and techniques aimed at preventing defects, identifying and resolving issues, and improving overall quality throughout the entire lifecycle of a product. QA aims to ensure consistent and reliable performance, and compliance with regulatory requirements. Quality assurance is defined by ISO 9000 as a “part of quality management focused on providing confidence that quality requirements.
What role does Quality Assurance play in pharma?
Quality Assurance (QA) plays a crucial role in the pharmaceutical industry by ensuring the safety and compliance with drug products. Here are some keyways:
- QA ensure pharmaceutical products and processes comply to Good Manufacturing Practices (GMP) and other regulatory requirements set by agencies like the FDA and EU.
- QA oversees quality control testing, stability studies, and other quality assurance activities to verify the identity, purity, and potency of drug products.
- QA assesses and manages quality risks throughout the product lifecycle, from development to commercialization with the implementation of change control, deviation handling, and investigations to quickly identify and resolve quality issues.
What is the difference between Quality Assurance and Quality Control?
Here is the key difference between Quality Assurance (QA) and Quality Control (QC):
| Quality Assurance (QA) | Quality Control (QC) |
|---|---|
| Preventing defects before they occur | Detecting defects after they occur |
| Process-oriented | Product-oriented |
| Entire organization. Involves planning and implementation of processes | Inspection and testing teams. Involves checking products or services |
| Implemented throughout the entire production process | Implemented during or after production |
| To prevent defects | To identify and improve defects |
| Managing quality | Verifying quality |
