The use of prescription drugs is often essential to our health and well-being. As a result of scientific research in the fields of chemistry, biomedical, pharmaceutical, and medical industries, doctors can cure many diseases, slow down the progression of degenerative diseases, prevent infections, and save lives.
Therefore, it should come as no surprise that drug manufacturing is one of the most highly regulated industries in the world.
Calibration of Pharmaceutical Instruments
It is essential that the quality of medications around the globe be assured, and a number of regulatory agencies around the world have established actions in order to control, maintain, and guarantee a higher degree of quality in pharmaceuticals.
As part of the regulations, samples of final products must be tested in the Quality Control Laboratory. To ensure the accuracy of the testing results, these facilities require instruments that are expertly calibrated or verified.
The goal is to provide patients with safe and standardized versions of the medications they require. In addition, if the physicochemical properties of drug substances are not correctly measured, pharmaceutical companies may produce products of low quality or even harmful quality, putting the patient’s wellbeing at risk.
The use of inaccurately calibrated instruments or equipment has been linked to the measurement errors in at least one study, illustrating the importance of precise calibration. Given how crucial calibration is for the drug manufacturing industry, the need to establish valid methods, and frequency of equipment calibration becomes a priority.
Currently, the International Organization for Standardization (ISO) provides guidelines as well as national and international standards to promote best practices and improve industry operations. Therefore, in addition to the local and global regulations established by the various regulatory agencies, the drug manufacturing industry must adhere to ISO standards.
A critical aspect of the pharmaceutical industry is the quality of the environment within laboratories used for manufacturing and testing. Drug companies must comply with the strict federal guidelines that are in place to keep the public safe. Compliant cleanrooms are a fundamental part of maintaining the ideal conditions for drug manufacturing. In the pharmaceutical compounding industry, USP 797 and USP 800 play an important role in the creation and maintenance of contamination-free production environments.
In addition, HEPA filtered air circulated in a lamina configuration protects both lab personnel and product quality.
Allometrics understands the importance of patient and employee safety and the potential cost of measuring errors. Thus, we utilize only certified instruments and employ NSF accredited and CETA certified technicians.