Schools Training

The Many Directions of Pharmaceutical Quality Auditing

20 NOV 2012
Career Path : Pharmaceutical Quality Control

Quality control and quality assurance is an important part of any manufacturing industry. There are many reasons for this, ranging from good business practices to maintaining a critical level of health and safety standards. Toys and gadgets are tested to ensure they perform properly to meet customer satisfaction. Automobiles undergo extensive quality assurance audits to guarantee road safety. Here we understand the different degrees of importance attributed to quality control, from profits and brand reputation to saving lives.


Pharmaceuticals are one of the industries with a very strict system for quality assurance and control. Most countries have an agreed-upon set of standards to make sure new drugs and medicine are made up of, and produced with the highest set of quality standards. This is often referred to as Good Manufacturing Practice (GMP). With GMPs, there are three main parties involved: the manufacturer, the vendor or customer, and finally, a regulatory body. Pharmaceutical quality assurance audits can be performed by any one of the three parties in either an internal fashion, an external one, or a regulatory one, and each is important for different reasons.


Internal: Manufacture on Itself

An important first step in the manufacturing of pharmaceuticals is an internal system for pharmaceutical quality assurance. The advantages of this are that a manufacturer has complete inside knowledge of their manufacturing processes from start to finish, thereby missing no single aspect of production. The obvious disadvantage is that a manufacturer may be more motivated to approve the process with the interests of having their drugs on the market in a quick and efficient way.


External: Manufacturer on its Vendors

Once a manufacturer is confident in the quality of its product and procedures, they still need to make sure the vendors selling their drugs maintain their standards. This is good for the manufacturer for the integrity of their product as well as their brand. Some problems might arise if certain vendors have lower standards with the interest of selling more pharmaceuticals faster.


External: Customers on Their Manufacturers

Customers of manufacturers who act as vendors of their products need to do their own quality assurance and quality control. It is the vendors who have a more direct relationship to end-user doctors, hospitals and patients and therefore might be the final test to screen for bad product. The disadvantages to vendors come from when their test results are negative after the manufacturer produced positive results, thereby possibly delaying delivery of promised pharmaceuticals.


Regulatory: Regulatory Body on Manufacturers

The clear importance and advantage of regulatory testing is that these organizations do not have business, manufacturing costs, or deadlines as their primary concern. They guarantee quality pharmaceuticals that perform as advertised and, most importantly, are safe.


It may seem that manufacturers, vendors and customers, and regulatory bodies are working against each other, but this is not the case. Because of the risks and dangers of bad product, these different parts of the pharmaceutical industry are working together to make sure the right medicine is available to the right people at affordable costs and with minimal risk.




Visit the Academy of Applied Pharmaceutical Sciences for more information on programs for pharmaceutical testing.