Rx_Spayce

In this space, I share thoughts related to the world of pharmaceuticals. The series will appear under the similar title.

We all know, body keeps responding to n-things parallely at all times. A typical characteristics of LIFE. It is designed to take care of itself. However, since we don’t have any idea about it’s specifications, we keep stretching and working the way we want to. When it goes beyond the specifications and it’s design space, it gives signal in various forms like, not feeling well, pain, illness, discomfort….or if some physical damage , like injury,

At first gross look we do feel that we have good understanding of the symptoms, probable cause of the problem and it’s treatment but still it’s limited and too much is yet to be explored.

When it comes to the treatment, the medical intervention is solely based on use of drugs, whether it is surgical or non- surgical.

Therefore, drugs enjoy a very key position in the healthcare and their success depends upon the Quality of delivered drugs to the patient at the time of it’s administration.

Therefore, Quality of the drugs need to be monitored with great care because they have huge impact on the outcome of the therapy and risk of failure is very high. The cost of failure too is substantial. They can make or break the patient life. Keeping this background in mind, the Drug Quality System is to be designed.

Honesty plays a central role in successful implementation of Quality System.

In industry it is known as Good Manufacturing Practices or GMP. It is considered as one of the most complex tasks , like knowing the origin of thought or gravity. Some of the reasons of this complexity is poor understanding of the processes at molecular level, poor correlation between parameters and performance, complex system of body where it has to interact with life and show effect….

The issue in drug making and it’s quality control is not only doing it right BUT to develop a system has ability to detect if something has gone wrong like some process is not exactly followed, something is not added/ or added different quality or quantity, tested correctly.

The strength of GMP depends on the ability of the system put in manufacturing to detect deviation. This is bringing several technologies in to manufacturing.

To know whether given formulation unit like tablet, capsule, injection is correct and can be used is not possible to know at the time of administration and hence manufacturing controls become the center of the quality.

When you take a medicine and it doesn’t work , would you say that tablet was not of quality or you may think the diagnosis is probably not correct or dose may not be correct or sometimes it is also said that patient didn’t respond as expected.

Have a great time, will keep sharing….