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How to Ensure the Right Conditions for GMP Synthesis and Storage Requirements

Written by admin on . Posted in Gmp quality assurance, Radiolabeling, Tritium labeling

If you run or manage a company operating in the pharmaceutical industry, it is likely that you already understand and appreciate the strictures and norms that you have to enforce properly in order to end up with viable products that are reliable and without adverse effects. The importance of maintaining adequate environments for research, drug development, and production can be paramount in these settings, especially when it comes to processes like GMP synthesis and GMP quality control. Maintaining the correct levels of chemical purity by closely controlling and monitoring labs and clean room standards can be of paramount importance. The more knowledge and insight you can have regarding the manufacturing and quality processes involved in GMP synthesis, the better you would be able to tackle these challenges.


The adoption and maintenance of good manufacturing practices can be a central theme for companies operating in the pharmaceutical industry. When it comes to medicine and related products, there is very little tolerance or margin of error. A small problem can easily have important consequences and this is why it is important to follow industry best practices and stay within the limits of the recommendations and strictures provided by various regulatory bodies and agencies that govern drug development and production. Operating and maintaining a clean room or a set of clean rooms requires a thorough knowledge of these norms and this is where research and insight can prove to be crucial.


When it comes to being able to maintain GMP standards in your research and production facilities, it is first important to know what exactly those standards dictate. You can then juxtapose that information to use cases relevant to your own company and take things from there. Of special importance are measures that are put in place for assessing chemical purity and the conditions of the areas where you carry out GMP quality assurance procedures. Clean rooms can be an integral part of such operations and there are strict standards of environmental control which need to put in place in order to create consistent, reliable results. The more knowledge and insight you have, the better and easier it can be.


When it comes to GMP synthesis and GMP storage conditions, it can be important to know exactly what the standard requirements dictate. For example, outdoor ambient air in most urban areas can contain up to 35 million small particles per cubic meter of air. In contrast, a clean room with an ISO 1 certification allows no particles of that particular size and up to 12 per cubic meter per air of smaller particles. Apart from air quality and composition, you might want to keep a close eye on other important factors like internal temperature and humidity as there can very strict tolerances on these variables. These variables can quickly affect the conditions and the resultant processes can also become quickly affected. For this reason, it is important to monitor these conditions for GMP synthesis projects.


Fortunately, assessing conditions and keeping on top of your requirements has become a lot easier over time. With the help of modern technologies like sensors, a very close reading of the conditions can now be possible. This can allow you to keep these conditions under control to a very fine, granular degree with very little tolerance or margin of error. By installing the right sensors and constantly monitoring the data, even minute changes in these conditions can be assessed and corrected. In addition, there are other measures and failsafes you can have in place to deal with contingency situations. Lab fume hoods need to be properly installed and maintained to ensure smooth and consistent operation.


By paying attention to these important details, you can have a truly compliant and pristine working environment which takes care of adhering to good manufacturing practices. Attention to detail and making provisions for unforeseen situations can be of paramount importance and the use of the latest technological innovations can help you automate repetitive tasks. With this approach in mind, you can gain relevant information and insight and make informed decisions that can be of great benefit to your research, development, and production workflows in your company.

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