Quality Assurance (QA) refers to the set of organized procedures designed to ensure that pharmaceutical products comply with predefined specifications. These procedures encompass all activities and responsibilities necessary to ensure the effectiveness and acceptability of the drug’s quality. In essence, the goal of Quality Assurance is to detect deficiencies early or prevent them.
Quality Assurance is a broad concept, covering all aspects that could affect the quality of prescribed pharmaceutical products. The objectives of QA include: ensuring the effectiveness of the produced drug, ensuring the safety of the produced drug, and ensuring that the produced drug complies with pharmaceutical manufacturing regulations.
Pharmaceutical Quality Systems (PQS) have eight pillars, which are designed to deliver final pharmaceutical products with high quality. Pharmaceutical companies strive to enhance their profitability while helping patients by producing high-quality drugs. To achieve these objectives, these companies rely heavily on Pharmaceutical Quality Systems (PQS).
Throughout the lifecycle of a product, there is a monitoring system for processes and product quality, as shown in the table below, to ensure the continued capability of processes and controls in producing a product with the desired quality. Additionally, this system identifies opportunities for continuous process improvements.
Throughout the lifecycle of a product, there is a monitoring system for processes and product quality, as shown in the table below, to ensure the continued capability of processes and controls in producing a product with the desired quality. Additionally, this system identifies opportunities for continuous process improvements.
However, high-quality final drugs cannot be achieved without mentioning and implementing Good Manufacturing Practice (GMP).
GMP is a part of quality management that ensures products are consistently produced and controlled to meet safety, quality, and efficacy requirements for the end user. GMP includes the monitoring of processes, equipment, personnel, and the environment of pharmaceutical companies.
Implementing GMP can help reduce losses, prevent recalls, seizures, fines, and more. Overall, it protects both the company and consumers from negative events related to the safety and effectiveness of drugs. GMP covers every aspect of the manufacturing process that could be disastrous for the safety and efficacy of a pharmaceutical product, such as:
- Quality management
• Sanitation and hygiene
• Building and facilities
• Equipment
• Raw materials
• Personnel
• Validation and qualification
• Complaints
• Documentation and recordkeeping
• Inspections & quality audits
