InstructorRoyed Training
TypeOnline Course
Student Enrolled1
Price$180 USD / 9900 INR
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stability testing for pharmaceutical development training

Introduction

Who should attend

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About Stability Study

Stability Testing pharmaceuticals

This orientation training provides understanding of stability testing requirements for establishing shelf life under cGMP criteria.

The “Stability Study for Pharmaceutical Development” course is designed to provide a comprehensive understanding of the principles and practices involved in assessing the stability of pharmaceutical products. Stability testing is a critical aspect of pharmaceutical development and manufacturing, ensuring that drugs remain safe, effective, and meet regulatory requirements throughout their shelf life. This course aims to equip participants with the knowledge and skills necessary to design, conduct, and interpret stability studies for pharmaceuticals.

Moreover stability testing is mandatory as part of cGMP to demonstrate a pharmaceutical product meets its acceptance criteria throughout its shelf life. Hence, 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 Snapshots

  • Course Code: RYD-064
  • Title of the course: Fundamental Training in Stability Testing in Pharmaceutical Development [Microlearning Course]
  • Course Duration: 3 Days.
  • Nature of the course : Online micro learning course. So, course can be accessed online across anywhere 24×7.
  • Course Certificate : Certificate will be provided at the end of the successful completion of the course

This course is suitable for professionals working in the pharmaceutical and biotechnology industries, including scientists, quality control/assurance personnel, regulatory affairs professionals, and individuals involved in pharmaceutical research and development.

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.
  • Moreover, this course provides knowhow for Fresher/Beginners, Those who want to have a fundamental understanding how stability testing of pharmaceutical products are carried out.
  • 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.

Stability Study

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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Section 1Learning Sessions
Lecture 1Modules on Stability Study : Stability Study - Fundamental Understanding | Interchangebility | Reports | API & FPP Stability Study
Lecture 2Climate Zone
Lecture 3Stability Zone Finder
Lecture 4Stability Studies : Case discussions
Lecture 5Case Study: Stability Data for Zone IV countries
Lecture 6Accelerated and intermediate testing conditions
Lecture 7Long Term Stability Testing Requirements
Lecture 8Stability Study Protocol Development
Lecture 9Stability Data Sheet
Lecture 10Stability Study Section in Drug Registration Dossier
Lecture 11Testing Frequency
Lecture 12ICH Q1 : Stability Guideline | Matrixing | Bracketing
Lecture 13Matrixing
Lecture 14Bracketing
Lecture 15Stability Study of Processed Food  
Lecture 16Health Supplement - Stability Study | Study Design - Batch Selection | Testing Frequency | Reduced Batches | Storage Condition | Container Closure System 
Section 2Request for Course Certificate