Establishing FDA-Compliant Product Stability Testing Program

In the dynamic pharmaceutical landscape, each drug product possesses its own distinctive characteristics, stemming from diverse components, chemical and physical properties of APIs, manufacturing methods, excipients, formulations, and storage conditions. As a result, the establishment of comprehensive requirements for expiration and stability is pivotal in ensuring compliance with current good manufacturing practice (cGMP) standards for finished pharmaceuticals.

Join this exclusive webinar focused on regulatory requirements and cutting-edge practices to establish top-notch product stability programs. Gain valuable insights into FDA-compliant strategies for expiration dating and stability testing, perfectly tailored to various product types.

Why You Should Attend:

In just 60 minutes, you'll discover the strategic significance of implementing FDA-recommended good practices, ensuring your firm remains compliant and stays well-prepared against potential FDA enforcement actions. Stay ahead of the curve with heightened awareness as we reveal the latest perspectives of FDA on product stability testing programs.

This product stability testing webinar leaves no stone unturned, delving deep into the FDA's stringent drug stability guidelines for diverse drug products. Learn how to expertly design a product stability testing plan that can be seamlessly applied to both new and modified products within the pharmaceutical, biotechnology, and medical device industries.

Areas Covered in the Session :

Introduction of a Stability Testing Plan and Program

• Applicable Regulation and Requirements

General Stability Considerations Applicable to a New Product (i.e. Potency)

Storage Conditions

• Shelf Life Duration of Studies and Expiration Dates
• Container Closure Requirements

Sample Size

• Sampling Plan
• Handling and Analysis of Samples

Stability Schedule (Suggested Schedules for Conducting Stability Studies)

• Pre-approval and Post Approval Studies
• Stability Tests
• Reformulated Products
• Accelerated Temperature Studies
• Test Schedule Information
• Suggested Time Points and Expiration Dates Based on Testing Time Points
• Solid Dosage Forms Suggested Test Schedule
• Liquid and Semi-solid Types Products Suggested Test Schedule
• Reconstituted Products Suggested Test Schedule

 Temperatures of Studies Based on the Product Type

• Room Temperature Studies
• Elevated Temperature
• Refrigeration
• Freezing Temperature
• Special Humidity Considerations

Analytical Testing Considerations

• Quality Control Release Assays and Methods
• Criticality of the Choice of Test that are Stability Indicators
• Choice of Methods with Meaningful Data or Stability Indicator
• Method Attributes

Stability Testing Protocol Design

• How to Design a Protocol and a Report

Stability Testing Data Management and Trending

• Trending Data
• Expiration Dating Extrapolation Using Data

Manual versus Automated Data Management

Advantages and Disadvantages

You will also get answers to the following tough questions:

• For a medical device that has storage label of 15-30°C; Are stability studies at 15°C and 30°C or 25°C study sufficient?
• For a reconstitution study; product has an assigned expiration of 24 months; do I need to do reconstitution at 12 months (6 hours, 12 hours and 24 hours) and at 24 months (6 hours, 12 hours and 24 hours)?
• What is the accelerated storage for a product with real time storage of -20°C±5°C?
• Is it an industry’s practice to do study one year past expiration?
• If the regression predicts failure before product expiration, what is the next step to do in stability?

Who Should Attend:

• Quality Assurance Departments
• Quality Control Departments
• Regulatory Affairs Departments
• Research and Development Departments
• Compliance Departments
• Laboratory Professionals
• Operations Departments
• Consultants
• Everyone interested in Product Stability Testing Program

Course Director: KELLY THOMAS

Ms. Thomas has over two decades of cGMP hands-on industry experience in both pharmaceutical and medical device manufacturing operations. Her experience covers all Quality Systems; as well as, all areas of validation; including, process/product validation, facilities validation, CSV and 21 CFR Part 11, test method validation, equipment/automated processes and cleaning validation. Utilizing strategic thinking, risk based approaches, and Lean principles, she has demonstrated success in steering and managing complex projects within the pharmaceutical and medical device industries.