In the pharmaceutical industry, quality assurance (QA) is essential for ensuring that pharmaceutical products are manufactured to a safe and consistent standard.
QA is a very broad field that refers to any aspect that may affect a drug's quality during its research, development, manufacturing, and sales phases.
Quality assurance is a way of preventing mistakes and defects in manufactured products and avoiding problems when delivering products or services to customers; which ISO 9000 defines as "part of quality management focused on providing confidence that quality requirements will be fulfilled
- Pharmaceutical Quality System Elements
The elements described below might be required in part under regional GMP regulations. However, the Q10 model’s intent is to enhance these elements to promote the lifecycle approach to product quality.
These four elements are:
- •Process performance and product quality monitoring system
- •Corrective action and preventive action (CAPA) system
- •Change management system
- •Management review of process performance and product quality
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Pharmaceutical guideline only