Industries: Pharma / Biotech

Stability Programs for Determining Product Shelf Life

Course Director:  Priya Jambhekar

Course Fee: $2150.00 Regular Registration / $1950.00 Early Bird (30 Days in Advance) 

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


"It was the most relevant and thorough course for my work." Mitchell G., R.A. Quality Control, AGTC
"This course was very informative and contained great real world scenarios/examples relating to stability topics." Efren B., Senior Scientist, Analytical Development, Celgene
"The background material was very helpful and provided a good foundation to the applications of shelf-life assignments." David M., Director Quality and Analytical Technology, Ironwood Pharmaceuticals
"The course director did an excellent job putting things straight. This was the most comprehensive course I ever attended. I am grateful and I will take advantage of the information I received." Thomas B., QC Manager, Neovii Biotech
"The information presented in this course was very informative. The class was able to do group projects which was a significant aid in the understanding of course material. I am very impressed with the binder of handouts that was provided with the course and I'm sure that I will use it in the future." Sarah D., Research Associate, Isis Pharmaceuticals
"Excellent course for regulatory affairs personnel. The course content was very comprehensive and provided material that will be of great use to me and my colleagues." Alex P., Forest Research Institute
"The class was very informative and I highly recommend it!" Sarah E., Regulatory Affairs Associate I, Tyco Healthcare-Mallinckrodt
"The course was taught very well. Being new to the industry, I found it extremely useful. The course director is very engaging in the presentation and has my brain thinking about a lot of non-statistical issues (statistics is my specialty). Thank you very much!" Eileen D., Quality Engineer, Amgen
"Very informative course and the instructor was very interesting. There was a real effort to move through the information quickly, yet answered each and every question." Barbara D., QC Stability Supervisor
"Excellent course for someone new to the field. Instructor was very knowledgeable and presents well." Chris M., Quality Assurance Associate, First Horizon Pharmaceuticals
"Course was very helpful as an overview of stability issues.; Aniello P., Stability Manager, Glaxo (GSK)
"The course was very good. Notes provided are great and useful for future reference. I will definitely stay in contact for additional information.; Jennifer S., QE Analyst, Sanofi Pasteur


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.