The Importance of Quality Control in the Production of Pharmaceutical Products

The Importance of Quality Control in the Production of Pharmaceutical Products- In the branch of Pharmaceuticals, what matters most is the quality. Therefore, Pharmaceutical Companies are investing mostly in the R&D industry along with the bioinformatics industry for the cultivation of ethical manufacturing and production of products that are great in quality. Therefore, there is a higher emphasis on quality now more than ever. Hence, Pharmaceutical Companies have opened the doors of opportunity to provide their quality drugs through contract manufacturing or Third-Party Manufacturing.

There is a lot of care and concern that goes into producing products that are high in quality. Many factors are responsible for the quality assurance of products. In fact, the ISO says that a number of tests have to be done on the medicines before it is passed for consumption. The tests that are done on these medicines are done in three different stages of medicine production. There are several intricacies that have to be taken care of. Therefore, this article explains how quality Control is the most important branch of the Pharma production branch.

Quality Assurance Tests on Medicines

The steps of quality assurance are tough and require many exhaustive processes. This procedure is done in three stages. These are done firstly, solely on raw materials, key ingredients, and all excipients. Secondly, the tests are done on the intermediate stage of preparation. In this, the products and molecules are individually tested. The results that these tests yield determine what processes further take place. In the third turn of process, the finished products are tested and given for further packaging and then, consumption. Here are some of the factors that show how the process goes on.

• Some Diagnostic processes on all raw materials.
• method validation of medicinal excipients.
• Bioanalytical System validation for all components.
• The calibration process for all equipment.
• Authentication and method validation of analytical processes.
• Validation testing of all compendial procedures.
• Various compendial trials on finished products.

Therefore, these were some of the processes that should explain the format of how the process of testing works in a Pharmaceutical facility.

Requirements for Quality Functioning of Medicines

Medicine’s quality is determined by the method by which it is created and which guidelines its manufacturing follows. Therefore, there are certain standards a medicine has to pass to attain a certain level of authenticity and quality. As per Article 2 of the constitution of the WHO, it is necessary to “develop, establish and promote international standards with respect to food, biological, pharmaceutical, and similar products”. Hence, it is necessary to uphold certain standards when it comes to medicines production. For, instance the standards need to be perfect as per guidelines provided by the:

1. ISO (International Standards Organization): An Indian organization that has been monitoring the quality of medicines produced in our country for many years now. It makes sure that the excipients that are imported and exported abide by certain quality standards.
2. WHO (World Health Organisation): This institution helps keep the medicines, various excipients, and ingredients, safe and secure to ensure the high-quality of all substances. It also provides expert guidance and support to all medicine manufacturers in the country.
3. GMP/GLP: These are known as the institutions for Good Manufacturing Practices and Good Laboratory Practices. Within these organizations, the GLP promotes that the research and development fieldwork properly and ensure the safety and preservation of medicinal products. While the GMP ensures that the packaging and manufacturing takes place in ethical settings with great ingredients.

Conclusion

Quality Assurance and Quality Control is highly important in today’s day and age. Pharmaceutical Companies promise quality and you should be aware of what goes on behind the doors of Third-Party manufacturing. Therefore, we hope this article helped you out in considering which side of the business you would want to enter.