Stability Testing - Develop Stable Pharmaceutical Products
- Temperature
- Humidity
- Light
- To meet the defined specifications throughout the retest period.
- To meet or confirm the assigned expiration date/shelf life.
- To establish a re-test period for the active substance or drug product.
- To establish the Shelf life/Expiry date of the active substance or product.
- To define or recommend the appropriate storage conditions of the product.
- Do you want to understand how to design an effective stability program while applying the rules and regulations to your specific product type?
- Are you looking to overcome challenges associated with using data collected from stability studies effectively such as trending the data, applying the study results to determine their product's shelf life and how to do extrapolation and statistical analysis of the test data?
- Are you confused as to the extent and type of design of a Stability Program that you should initiate for a new drug?
- Do you want to maximize the use of your stability program testing data for extending your product's expiration dating?
- Are you facing challenges generating a Stability Testing Program Policy, Test Protocol and Report and their paper-based system into the use of the Lab Information Management System for your data management, trending, statistical analysis and shelf-life determination?
- Are you struggling with FDA's Form 483 and Warning Letter remediation work on stability testing program design/requirements and various aspects of Quality and Compliance remediation?
Simply creating an efficacious compound is not enough in drug development. When administered, the drug substance must be stable and achieve its target. Even during storage, transport, and distribution, the drug product must not lose its stability.
It is possible to control the environment often. However, sometimes a drug product can be exposed to conditions such as extreme sunlight and heat or cold. For instance, consider a situation when a patient may forget his medicines in a car and park it in extreme sunlight. Uncontrolled conditions make stability testing crucial. Stability testing helps find out if the product degrades under varied conditions.
As a key part of the lifecycle of a pharmaceutical product, stability testing plays an important part during product development, regulatory review, and commercialization.
The function of stability testing is to provide evidence on how the quality of an active substance or pharmaceutical product varies with time under the influence of environmental factors such as
Stability Testing Program and data are used for the following:
Drug Substance and Drug Product Stability Testing
Drug substances and drug products are different from each other.
| Drug Substance | Drug Product |
|---|---|
|
Drug substance is the Active Pharmaceutical Ingredient (API) without excipients. |
Drug product is the finished dosage form that contains the drug substance. |
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Drug substance is obtained before product development during the early drug development. |
Development of drug product follows the development and formulation of drug substance for the drug product. |
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Drug substance is obtained after candidate selection |
Drug Product testing can be done in suitable media for dissolution testing prior to clinical studies to gain information on how the drug product will dissolve in vivo. |
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Understanding the drug substance's physiochemical properties and solubility before developing drug product is important to guide the formulation strategy. |
The stability testing regimen is different for product. |
Challenges?
Stability Training to Help You Navigate the Challenges
Designing and Sustaining New and Existing Product Stability Testing Program
This Virtual Seminar will provide a great resource to Pharmaceutical, Biotechnology, Diagnostics, Cell Therapy, Drugs, Biologics, OTC, Radio-pharmaceutical, Pharmacies and Medical Device Industries in understanding the effective way to establish a new or modified product stability testing program. This program is an important part of a product's regulatory filing requirements as well as the determination of the shelf life or expiration date of the product. The focus of this seminar will create a detailed process that will guide the attendees in the right direction in the planning of a new or existing product's stability testing plan, program, protocol, handing and utilizing the data, setting the shelf life as well as the applicable regulatory requirements.
Stability Studies and Estimating Shelf Life
In this webinar attendees will learn the useful methods and techniques for conducting a stability study and analyzing the resulting data for estimating shelf life. The interpretation and communication of results will be emphasized and illustrated using several examples.
Properly Investigating and Remediating OOS Results
This webinar will review the regulatory requirements for investigating an OOS Investigation. The responsibilities of the analyst, the supervisor and QA will be discussed. A detailed flow chart will be used to help the attendees clearly understand the steps and the order in which they are to be performed. The structure of an Investigation report which properly documents the investigation will be discussed.
ICH Stability Requirements and Challenges
This 90-minute webinar will clarify your confusion about Test Article Characterization for GLP drug studies. You will learn the correct way to use GMP characterization data in a GLP study, understand how to characterize a medical device as a test article, learn the common mistakes made in test article characterization and the basic requirements for drug and device stability testing.
