why stability testing is important in medicine manufacturing

Introduction

The pharmaceutical Sector is based on testing and experimenting. There are different tests in this industry, but Stability testing in the pharmaceutical industry is important. 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 products is the numerical analysis of how long a pharmaceutical product can be stored without changing its original chemical composition. Pharmaceutical products undergo certain changes once they are stored for a long duration and start releasing by-products. Stability testing provides 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, photo stability, 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. This stability testing has opted to keep an eye on the same and to study the shelf life of a product. This test studies how long a pharmaceutical product can be stored at normal or exaggerated conditions. This study helps to decide or determine the product's shelf life; even the product's expiry date 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 product's shelf life.

• It is the effective and best way to study the effectiveness of a new product by assessing its physical, chemical, and therapeutic stability.

• The pharmaceutical industry works on quality. Once the products are tested under adverse conditions, the purity of ingredients and quality of the final product also gets checked. 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 Pharmaceutical 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 among the 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.