Events – Glostem

Overview

Pharmaceuticals by regulation are required to bear an expiry date on their labels. The purpose of the said date is to restrict the use of a product to a time period within which the manufacturer guarantees its efficacy, safety and quality. This is true not only for new drugs and products, but also generics, OTCs, extemporaneously prepared preparations, veterinary formulations, dietary supplements/nutraceuticals, complimentary and alternate therapies (homeopathic, ayurvedic, unani, siddha, or any other systems of medicines), medical devices, and even cosmetics. There can be serious consequences for the manufacturer if a product fails to comply with the declared specifications any time till the expiry date.

The expiry date is determined through stability testing, a process that starts from the cradle and lasts till the grave of the drug or its product. Stability testing means a set of studies utilised to determine if the quality of a drug substance or drug product would vary with time under the influence of various extrinsic (environmental) factors, such as light, temperature, and humidity, and intrinsic factors like oxygen, moisture, pH, excipients, packaging, etc. It is an intricate exercise, which gives no tangible benefit, except providing confidence to both the producer and the patient that quality of a pharmaceutical will remain within the acceptance criteria till the end of shelf-life. Hence stability testing is rightly said to be key to drug and product quality.

This masterclass has been designed to refresh the pharmaceutical scientists working in the chemical, formulation, regulatory and analytical R & D with the most important information related to conduct of stability studies in pharmaceutical industry so that they can design and execute an effective and successful study program. This masterclass will be held in physical mode in Vizag on December 15, 2022.

Who Should Attend

Scientists, Senior Scientists, Managers, Research Associates from Pharmaceutical industry from Research, API/Formulation Manufacturing, Analytical, Regulatory departments, CROs and Testing Laboratories as well as experts in Pharmaceutical Stability Testing and Impurity Profiling, Pharmaceutical Analysis as well as Organic Synthesis. This masterclass is ideal for scientists with experience ranging from 0-7 years.