Who should attend
About Stability Study
This short orientation training provides fundamental understanding of stability testing requirements for establishing shelf life under cGMP criteria. Stability testing is mandatory as part of cGMP to demonstrate a pharmaceutical product meets its acceptance criteria throughout its shelf life.
It is important for pharmaceutical manufacturer to establish sustainable stability program in compliance with current regulations is therefore critical to development of new pharmaceutical products. Therefore, stability guideline need to be followed as specified by the regulatory agency. And stability results should be incorporated in the drug dossier which in turn submitted to regulatory agency.
In this online self-paced modules, participant will be understanding about the requirement of the stability study. The course provide valuable insight stability guideline for finished pharmaceutical products, as well as active pharmaceutical ingredients.
Course Code: KPE-C-064
Course Title: Fundamental Training in Stability Testing in Pharmaceutical Development [Microlearning Course]
Online micro learning course. So, course can be accessed online across anywhere 24×7.
Duration: 3 Days
Any body who wants to acquire detailed understanding on new drug approval pathway, should attend the course.
Any body who wants to acquire competency regarding new drug development process, should attend the course.
Who should attend this course?
- This course is ideal for those who requires detailed stability program understanding. For example, those working in Analytical Development, Analytical Chemistry, Stability Testing, Formulation Development, Regulatory Affairs, Pharmaceutical & Biopharmaceutical Production, Product Development, Technical Operations.
- Fresher/Beginners, Those who want to make a career in drug regulatory or pharmaceutical products.
Certificate will be provided at the end of the successful completion of the course
- This course provides detailed understanding on stability program which need to be adopted by the pharmaceutical producers. Hence, this course is ideal for the regulatory, QA/QC professions, or those who are handling drug dossier for regulatory submission.
- The course focus on the implementation of stability study.
- Moreover, course also provide clear cut understanding of the various stability zones.
- Finished pharmaceutical and active pharmaceutical ingredients stability program covers under the course.
Few of the similar courses
Stability studies are performed in life sciences, chemical, and food and beverage industries to determine the effects of environmental conditions on product quality. Environmental conditions can impact product shelf life, and the viability of product formulation.
Stability testing provides evidence on how the quality of a drug substance or product varies over a given time period and under the influence of environmental factors including temperature, humidity and light.
The studies are designed to include testing of attributes susceptible to change during storage and are likely to influence quality, safety and efficacy.
Testing primarily covers physical, chemical and microbiological attributes:
- Physical: Appearance, melting point, water content, clarity and colour of solution, pH, dissolution and disintegration characteristics, viscosity, crystal modification or particle size
- Chemical: Assay, degradation products, related substances and residual solvents
- Microbial: Growth in microorganisms and efficiency of preservative contents such as antioxidants and antimicrobial preservatives
Shelf life is the recommended maximum time for which products or fresh (harvested) produce can be stored, during which the defined quality of a specified proportion of the goods remains acceptable under expected (or specified) conditions of distribution, storage and display.
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