Quality assurance and quality control of pharmaceutical formulations and bulk pharmaceuticals both heavily rely on pharmaceutical analysis. The demand for new analytical techniques in the pharmaceutical industries has increased due to the pharmaceutical industries' rapid expansion and the manufacture of drugs in different parts of the world. Development of analytical methods has therefore evolved into the core function of analysis. The advancement of analytical tools has led to recent developments in analytical instruments.
Analytic method development is a key element of any pharmaceutical drug development program. Both the pharmaceutical development process and the assessment of drug products to fulfil the requirement of potency, purity, and stability require reliable and reproducible analytical methods. Method development is a continuous process that progresses simultaneously with drug development.
Analytical methods are improved and broadened as drug research goes along based on an increasing understanding of the drug product. Method validation is necessary when the drug moves through clinical trial Phases 2 and 3, as well as commercialization.
Through digital innovation, there has been development of better analytical methods and tools which has resulted in shorter analysis times, greater precision and accuracy, and lower analysis costs. As a result, the majority of pharmaceutical companies are spending a sizable sum of money to create cutting-edge analytical laboratories. For active pharmaceutical ingredients (API), excipients, drug products, degradation products and associated substances, residual solvents, etc., analytical techniques are developed and verified. As a result, it is now an important factor of what the regulatory organisation requires. Official test methods are the end product of analytical method development. In quality control laboratories, these techniques are used to guarantee the identification, purity, safety, efficacy, and performance of drug goods. Analytical methods are becoming more important in manufacturing, according to regulatory authorities.
Join us on 28th - 29th March, 2023 for the International Bioprocessing and Biologics Forum, in Berlin, Germany as our panel discusses various digital innovations to accelerate analytical development so you don't feel left out in the industry!
To register or learn more about the Forum please check here: https://bit.ly/3zxguXW
For more information and group participation, contact us: [email protected]
