Manufacturing Process and Quality Management of Pharmaceuticals
All of manufacturing industry has an overriding concern for quality. This means they want to make products 'right first time' without any flaws or defects. The drive to maintain this quality is called Total Quality Management (TQM). There are three main aspects of TQM that are distinctive to the pharmaceutical industry.
The long development time
Once a promising molecule has been found, it can take up to 12 years to the launch of the medicine. This is much longer than, say, the development of a new car. However, it is essential to allow the company to ensure that the medicine is acceptably safe.
The license and the production processes
The manufacture of a motorcar can be changed once it has started. However, in the pharmaceutical industry a license has to be granted before a medicine can be produced. Its issue depends on the production process. Therefore, once the license has been issued, it is very difficult to change the process. This means that the production process must be carefully planned at the very beginning.
An overriding concern for safety
This can be seen by the use of strict quality control systems. These exist at all stages in the manufacture and trialling of the new medicine and include:
Checking the safety of a medicine through extensive trials
A system for tracking each stage in the production of a batch
Heavy investment in training.
Pharmaceutical companies devote a lot of time to training. They encourage their staff to take responsibility for their work. They can't rely on someone else making up for their mistakes. They know that their contribution has to be perfect for the medicine to be as safe as possible and for the company to succeed.
Pharmaceutical manufacturing is a high technology process. As well as, relying on the skill and knowledge of their employees, pharmaceutical companies use high precision and efficient control systems. They are major employers in this country and contribute significantly to the economy. The industry seems to have a good future but, as with anything successful, it cannot be complacent and remains a dynamic, developing industry.