Food and NutritionPharmaceutical

Quality Assurance

Quality Assurance

According to Kozier, Quality Assurance is an ongoing systematic, comprehensive evaluation of health care services and impact of those services on health care services”. It is a wide concept that covers all aspects that collectively or individually impact the quality of the product i.e. sum of organized arrangements that are made with an aim of ensuring pharmaceutical products are of required quality as per intended use. Neetvert defined it is defined as all activities undertaken to predate and prevent poor quality.

Planned and systematic activities implemented within the quality system that can be demonstrated to provide confidence that a product or service will fulfill requirements for quality.  It is a system for evaluating performance, service, quality of a product against system, standard or specified requirement for customers.

It is the totality of the arrangements made with the object of ensuring that products are of the quality required for their intended use. Quality assurance therefore incorporates GMP and other factors, including those outside the scope of this guide such as product design and development. Appropriate quality assurance is important in the pharmaceutical industry.

Quality assurance is a process used to determine if product or service is up to standards, and whether customers are getting the kind of product or service that will keep them returning. The idea is to deliver a product or service that consistently keeps up a high quality. It’s a proactive approach where defects are detected before a product or service goes into market/Public.


Assurance of Quality


In developing products and services, quality assurance is any systematic process of checking to see whether a product or service being developed is meeting specified requirements. It is an obligation that ensures manufacturers meet the needs of end-user needs in terms of safety, quality, efficacy, strength, reliability and durability.

A quality assurance system is said to increase customer confidence and a company’s credibility, to improve work processes and efficiency, and to enable a company to better compete with others. Nowadays quality assurance systems emphasize catching defects before they get into the final product


Need/Importance of Quality Assurance

  • It helps to meet demands and expectations of clients. High quality builds trust with customers, which, in turn, makes the products competitive in  market.
  • Helps to plug loopholes that could cause loss to business.
  • It can reduce extra costs that come with retesting, replacing and reselling faulty goods.
  • Might  save a company money in legal expenses, especially if its product isn’t up to industry standards.
  • It saves costs and fixes issues before problems become larger, and  helps to set and maintain quality standards by preventing problems.

E.g. Pharmaceutical industry saw an increase in regulation after 1957 thalidomide disaster.  (Thalidomide disaster is one of darkest episodes in pharmaceutical research history. The drug was marketed as a mild sleeping pill safe even for pregnant women. However, it caused thousands of babies worldwide to be born with malformed limbs. This damage was revealed in 1962). so quality assurance of pharmaceuticals is of great importance.


Leave a Reply