What is Quality assurance?
In January and February 1986, 14 people died in the J.J. Hospital after being given glycerine (or glycerol), a routine anti-oedema drug used to combat swellings. The glycerine was contaminated with di-ethylene glycol, a chemical which kills quickly by attacking the kidneys. It is a classic case of negligence, human greed and failure of checks and controls.
Quality assurance is a principled exercise in the manufacture of pharmaceutical products. It is the process of affirming the integrity of products to meet the standard for the proposed use. The inferior, low quality, fake and adulterated medicine is a threat to the public health, and therefore the pharmaceutical industry is very keen to maintain the stringent, scientific, and systematic approach in the production of pharmaceuticals. Every manufacturing house, service organisation even the process need to ensure the quality of their products to gain the confidence of their customers. The products should meet the set quality standard. To ensure compliance with the standards, the organisation defines quality control and quality assurance protocols. That leads to the question of what is quality. It is about the products meeting the needs and expectations of the end users concerning to functionality, design, reliability, durability & price of the product.
The quality of pharmaceuticals has been a concern of the World Health Organization (WHO). WHO states that the pharmaceutical industry should develop, establish and promote international standards concerning food, biological and pharmaceuticals. The supply of essential medicines of good quality should be considered as one of the important obligations for the pharmaceutical industry. Pharmaceutical industry worldwide is the most regulated industry. Drugs, medical devices, nutraceuticals, or the end products of the industry have a direct bearing on human and animal health. A substandard, spurious medicine can cause unimaginable damage. Therefore an elaborate system of quality assurance is required to ensure quality is put up in place by the pharma companies. Thousands of experts who have a thorough understanding of quality concepts are required world over.
Quality assurance program offered by the Pharmacy institutions in post graduate level is an attempt to address the human resource requirements. The program covers important areas such as the importance of quality, ISO management systems, tools for quality improvement, analysis of the product quality, quality evaluation, validation of process and product and stability testing, Total quality management (TQM), WHO cGMP requirements, NABL certification & accreditations, Good laboratory practices (GLP), Good manufacturing practices (GMP), Good clinical practices (GCP) are the key components of quality assurance.