Stability Programs for Product Shelf Life - From Development to Approval

Because of its comprehensive content, this course will be valuable to personnel in research and development, regulatory affairs, manufacturing, quality assurance, and the quality control laboratory, who are involved in conducting, supervising, or managing stability testing. This includes those whose job responsibilities require an in-depth knowledge of the FDA regulations and ICH guidelines as applied to establishing stability programs and conducting stability testing.

Learning Objectives

Providing the step-by-step foundation for stability testing, this comprehensive training course outlines the issues and guidelines surrounding FDA and ICH regulatory requirements. Specifically, this course will focus on establishing a successful stability program by in-depth discussions on writing and revising stability protocols, stability sample management, stability indicating assays, out of specification results, and deviations. Sample 483’s are reviewed to better understand typical deficiencies and how to avoid them. Practical techniques are reviewed to improve the integrity of the stability data and ensure that test results comply with FDA and ICH requirements. By the end of the two-day course, attendees will gain the skill set to interpret regulatory guidelines, design compliant stability program, and effectively prepare for an FDA inspection in their stability testing laboratory and sample storage facility.

Course Description

This continually updated course covers current FDA regulatory requirements and ICH guidelines as applied to designing stability programs from the early stages of product development all the way to approval. Among the topics to be discussed will be: identifying FDA’s regulations and ICH guidelines for stability testing, writing study protocols and SOPs, designing and validating stability indicating analytical test methods, establishing Successful Stability Data Management Systems, conducting and documenting OOS results and deviations, and preparing for an FDA inspection of stability program.

Additional benefits of this class include:

• All participants receive a Resource CD with: a Reference List, 483s, Key Guidance Documents, and more
• Learn not just from the director, but tap into the knowledge of your peers: Participants will have the opportunity to anonymously submit their top stability challenges, problems, and issues for classroom discussion
• Participants will also have the opportunity for one-on-one consulting with the course director during course breaks and in the evenings. The course director has over 15 years of industry experience, over 8 years of consulting experience, and over 10 years of experience directing training courses

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COURSE AGENDA

FIRST DAY

Review the Fundamentals of Stability Testing Requirements
• Introduction and review of goals and objectives
• A general overview of stability program’s requirements

Regulatory Guidelines Governing Stability Testing Operations
• Identify Current ICH/FDA Guidelines: Q1A (2R), Q1B, Q1D, Q1E and Q5C guidelines
• Review current Q1A (R2)

Elements of Stability Testing Operations Components of Stability Protocols
• Storage operations
• Sample traceability
• Laboratory Information Management System (LIMS)
• Group Exercise: Author a stability protocol

Design Compliant Bracketing and Matrixing Strategies for Stability Testing
• Define bracketing and matrixing
• Review ICH Q1D
• Group Exercise: Create a Matrixing design
• Group Exercise: Create a Bracketing design

Design Compliant Photostability Studies
• Review ICH Q1B
• Practical considerations of photostability studies:
o Chambers
o Light sources
o Scientific principles

SECOND DAY

Stability of Products
• Review ICH Q5C
• Selection of batches,
• Sample selection
• Stability –indicating profile
• Storage conditions
• Containers/closure systems
• Specifications
• Testing
• Labeling

Validation of Analytical Methods for Stability Testing
• Types of Analytical Procedures to be Validated:
• Identification tests
• Quantitative tests for impurities' content
• Limit tests for the control of impurities

Evaluation of Stability Data
• Review ICH Q1E
• Data evaluation for drug substances
• Data evaluation for drug products

Out-of-Specification (OOS) Stability Results
• Define elements of an OOS investigation
• Analyze regulatory and legal consequences of OOS results
• Generate accurate investigational data
• Determine root cause for the OOS result
• Establish scientifically sound and well documented stability results in a timely manner
• Provide compliant investigational documentation
• Implement appropriate corrective action
• Group Exercise: Investigate an OOS result

Out-of-Trend (OOT) Stability Results
• Define elements of an OOT investigation
• Determine potential regulatory and business consequence of OOT

Prepare for an FDA Inspection of Your Stability Labs
• Preparations for an FDA inspection
• Inspection day
• Responding to Observations
• Most cited FDA observations on stability programs