Why Stability Testing is Important in Medicine Manufacturing?

Posted by Akums Drugs & Pharmaceuticals Ltd on October 22nd, 2022

Introduction

The pharmaceutical Sector is based on testing and experimenting. There are different types of tests taking place in this industry but Stability testing in the pharmaceutical industry has major importance. It is integral to develop new pharmaceutical products and active pharmaceutical ingredients to set up their shelf life or expiry date.

Relevance  

Stability testing of drug substances and productsis the numerical analysis of how long a pharmaceutical product can be stored without any change in its original chemical composition. Pharmaceutical products tend to undergo certain changes once they are stored for a long duration and start releasing by-products. Stability testing assists in terms of providing facts on how certain pharmaceutical drugs can be stored at room temperature and in controlled situations.

The constancy of manufactured goods means how extensive that product can be kept under usual circumstances without degradation. With time, noticeable changes may take place. The constituency of the product varies over time. The stability of any product is affected by a variety of environmental factors. The stability of a product largely depends on warmth, dampness, photostability, processing, management, and storage conditions.

Reasons for Opting for Stability Testing

There are many reasons why stability tests of pharmaceutical products are considered significant. Let's explore the possibilities:

• Pharmaceutical drugs undergo many changes during extreme conditions. To keep an eye on the same and to study the shelf life of a product this stability testing has opted.. This test studies how long a pharmaceutical product can be stored at normal or exaggerated conditions. This study helps to decide or determine the shelf life of that product, even the expiry date of that product is also revealed.
• Different pharmaceutical products are stored under different storage conditions. During this testing storage conditions and changes in the substances are recorded which further generate facts to recommend or decide the storage of that product.
• Stability testing gives a clear picture of all the ingredients used to manufacture pharmaceutical drugs moreover they get analyzed under various environmental factors. This makes the process easier to identify and eliminate any impurity that is formed during the shelf life of the product.
• It is the effective and best way to study the effectiveness of a new product, by assessing its physical, chemical, and therapeutic stability too.
• The pharmaceutical industry works on quality. Once the products are tested under adverse conditions, the purity of ingredients and quality of the final product are also gets to check. This test ensures that these products are fit for human consumption which further builds up the confidence of the companies to launch their products successfully in the market.
• After going through different testing situations, packaging materials are chosen for the product. The ideal packaging should tolerate stress or adversity. The packaging should also ensure that the quality of the product will remain intact during transportation and storage.
• Stability testing is required for regulatory approvals too. If the product tested under different circumstances, doesn’t meet the quality standard prescribed, then the product will not get approval for commercialization.

Akums Drugs and Pharmaceuticals Ltd.

Akums Drugs and Pharmaceuticals Ltd. is a worldwide famous WHO-GMP-certified contract manufacturing organization. It holds a good reputation and high esteem as the Third Party Manufacturer for Pharma. They ranked highest amongthe Third Party Manufacturing Pharma Companies.Stability testing is an integral part of their product manufacturing which they do with proficiency, based on innovative approaches and sound technology.