FDA Regulatory Compliance Training
Course Description -
Quality assurance studies for active pharmaceutical ingredients (APIs) and pharmaceutical drug products, both chemical drugs and biologics, are essential for product quality and patient protection. The goals of the stability program are (1) to determine an appropriate and safe stability profile during clinical development and (2) to justify a shelf-life for the product to enter the market for FDA regulatory compliance,
The approach to stability testing and interpretation of stability data has undergone significant change. Strategic international ICH regulatory guidance’s have been adopted that are driving the entire pharmaceutical industry, including both chemical drugs and biologics, to a higher standard of performance, including Quality by Design (QbD), Quality Risk Management (QRM) and Pharmaceutical Quality System (PQS).
Therefore, it is most important for a pharmaceutical company to have an effective and regulatory compliant stability program strategy that can meet both FDA and EMA requirements and expectations. At each stage of drug development, from Phase 1 through commercialization, the basic question needs to be addressed: ‘What is absolutely necessary from the stability program to be successful in getting the chemical drug/biologic through clinical trials and into the market, but without impacting patient safety or creating delays in the program?' Regulatory compliant deficiencies in stability program have resulted in clinical holds and market approval delays.
Who Should Attend
This two-day product shelf life course is designed for directors, managers, supervisors, project planners, analysts, and professional staff seeking to understand, develop or implement a regulatory compliant stability program for their pharmaceutical chemical drug or biologic product. Typical attendees include: Management, Project Managers, Regulatory Affairs, Manufacturing, Quality Assurance, Quality Control, Formulation Development and Analytical Development personnel.
This product shelf life course will help the attendee to design and implement a stability program meeting global stability requirements and expectations. Participants will also become effective in interpretation of stability data.
Course Agenda
First Day
Why Product Stability Profiles Are Necessary
Terminology defined: shelf life specification, expiration date, shelf life, stability-indicating assay, re-test date, in-use period
Long-term vs. accelerated vs. stress (forced degradation) testing – value and limitations
Patient safety impact of an ineffective product stability assessment
Regulations and Guidances on Product Stability
Regulatory stability requirements – FDA and EMA
ICH Q, FDA, EMA, WHO and pharma industry stability guidances – similarities and differences between chemical drugs and biologics
Handling out-of-specification (OOS) stability test results
Clinical Phase-Appropriate Stability Programs
Preliminary stability assessment for early stage clinical development
Thorough stability programs for late stage clinical development
Significant differences between API and DP stability studies, and between FDA and EMA stability expectations, during clinical development
Stability Program Prerequisites
Critical importance of an effective stability sample tracking system
Appropriate and adequate qualification, maintenance and calibration of stability chambers/storage units
Selection of relevant stability-indicating test methods – similarities and differences between chemical drugs and biologics
Second Day
Effective Design of a Formal Stability Protocol
Role of Quality by Design (QbD) in the formal stability program
Key stability study parameters – batch selection, storage conditions, testing frequency, stress conditions, in-use period
Bracketing and matrixing study design
Statistical Approaches to Setting Shelf Life
Understanding of basic statistics - mandatory
Regression line and Arrhenius plot extrapolations
Defining what is a ‘significant change’
Preparing CTD Regulatory Submissions on Product Stability
Stability data presented in Module 2.3 Quality Overall Summary, and Module 3 Quality of the CTD – minimum data requirements and formatting
Post-approval stability protocols and stability commitments
‘Stability budget’ and product distribution stability study reporting
Managing Regulatory Authority Stability Interactions/Inspections
Inspector interest in product stability studies – what they want to see and why
Regulatory report card on pharmaceutical stability programs – case examples in Warning Letters and cGMP certification withdrawals
Ultimate regulatory authority concern – stability data fabrication
Please Note: This course primarily covers pharma products. Medical Devices are not addressed in this training program.
Learning Objectives
At the end of the two-day course attendees will:
Gain a solid understanding of the regulatory compliance requirements and expectations (FDA, EMA, ICH, WHO) for API and drug product stability programs, for both chemical drugs and biologics
Have the tools and understanding to develop and implement a regulatory compliant stability program that is clinical phase-appropriate, incorporating Quality Risk Management (QRM)
Understand the ICH Q8, Q9 and Q10 Quality by Design (QbD) approach applied to the stability program as part of an effective control system
Be able to appropriately package stability information into Module 2.3 and Module 3 of the Common Technical Document (CTD)
Learn how to avoid major delays in clinical development or market approval due to an ineffective stability program
Videos
VIDEO
CfPIE Stability Programs Course: Attendees Speak Out
Hear from three attendees of CfPIE's 2-day "Stability Programs for Determining Product Shelf Life – From Clinical Development to Market Approval" course and learn, in their own words, how they expanded their knowledge on properly running a compliant stability program.
