Developing an Application Model for Improving Quality of Pharmaceutical Manufacturing Based on the Quality Principles – Covering Quality Improvement and Quality Assurance Audit

The term “Improvement” in this context refers to creating beneficial change and achieving unprecedented levels of performance. Quality improvement in products is crucial for enhancing customer satisfaction, reducing dissatisfaction, and minimizing waste, leading to improved company income. This discussion focuses on two types of beneficial changes: enhancing customer satisfaction through product features and achieving freedom from deficiencies that cause dissatisfaction and waste. Recommended actions include understanding customer needs through surveys, analyzing deficiencies to improve products, reducing losses, improving yields, establishing a dedicated product and process development department, empowering shop floor operators, implementing systematic procedures for measuring improvement goals, and motivating employees through rewards. These actions aim to increase profitability, reduce costs, and ensure continuous improvement. Quality assurance involves establishing confidence in meeting quality requirements through activities such as quality audits, which systematically examine adherence to predefined processes. The World Health Organization (WHO) and the Medicines Control Council (MCC) provide definitions of quality assurance emphasizing the importance of meeting quality standards. Dr. Joseph Juran's concept of quality assurance emphasizes specification compliance, and quality audits, both internal and external, play a vital role in assessing and verifying quality activities. The principles of a quality audit program include fact-based judgments, providing assurance to management, identifying areas for improvement, addressing human relations, ensuring auditor competence, and contributing to an enhanced quality management system