Ever wondered what particular factors are needed when considering coming up with an API production process?
This question has been answered by many professionals using all kinds of different methods. Let’s take a look at the different approaches they used to come up with the API manufacturing process.
According to Van Kley, the api manufacturing requires a number of factors for the development process. He put emphasis the organization’s involvement by saying that it should have the complete capacity, capability and mechanism to handle all the required reagents and any solvents. He also stated that the company should also be able take care/handle all the temperature ranges involved in api manufacturing. He did not stop here as he went further to explain on the importance of safety implications and specified hazards that should be put into complete consideration when carrying out the process.
Another scientist going by the name of Goeddel focused on the aspect of purity that is very crucial for api manufacturing. He told all the manufacturers to always ensure that they take utmost carefulness when looking at the overall purity, level of impurities, and the purity profile to make sure that they meet the internationally accepted standards. In any case there was doubt, the International Council Form Harmonization (ICH) has given the guidelines on the threshold limits in case of any impurity identification.
Throughput was said to be the most crucial factor when it comes to manufacturing of APIs and is not to be left behind in any case. This is because it’s said to bring in the aspect of improvement on the yields of the APIs which in other words brings about reduction on costs and minimization on the amount of wastes. If all these factors are put in place and greatly considered then the manufacturing company as well as the patients and the general environment will greatly benefit from API.
For a higher growth rate of the api manufacturing industry, API purity, yield, impurity levels and the safety process, any activity should not be neglected at any particular point. This will also mean production of superior drugs for medicinal purposes with no or very minimal side effects to all its consumers.