Stability & Shelf-Life Testing

Today's challenge for many manufacturers is to meet both FDA and International Conference on Harmonization (ICH) guidelines. The intent of these guidelines is to clarify and raise basic testing standards. They are being incorporated by regulatory bodies around the world towards the creation of a standardized worldwide regulatory environment. LABVANTAGE Stability. LABVANTAGE Stability, a fully compliant solution that fulfills the paramount need for well-documented stability and shelf-life studies, was created to address these industry trends.

Stay 100% Compliant

LABVANTAGE Stability fulfills the needs of Companies that operate in regulated industries, including pharmaceutical, contract services, health & personal care, and food and beverage. These industries have long been involved in stability testing due to the requirements stipulated in 21 CFR 11.

In addition, new industry sectors are now being required to perform stability testing, which is creating analytical challenges for them that they had not previously encountered. Suppliers of bulk active pharmaceutical ingredients (API) and raw materials manufacturers must now have stability data for their products. Manufacturers of vitamins and supplements with botanical ingredients, while not yet required to meet the same regulatory requirements as drug manufacturers, are finding it beneficial to have dependable stability data to back up their label claims and expiration dates.

LABVANTAGE Stability helps these organizations ensure that products distributed to the public remain chemically and structurally unwavering once they are released, and allows them to determine

• Potency of a product throughout its entire shelf-life to establish expiration dates
• Effects of packaging material combinations
• Effects of UV rays (product discoloration, etc.)

Full Control of Your Stability Study Lifecycle

LABVANTAGE Stability allows you to control every aspect of the study lifecycle in a simple and logical fashion. Each phase of stability study management, from definition to release, can be automatically documented for regulatory compliance.

LABVANTAGE Stability allows you to manage complex protocols with multiple batches, packaging types and storage conditions and define a virtually unlimited number of sample pulling schedules. Stability supports orientation of the container storage and different types of testing including repeats, per container testing, destructive tests, and container reuse (weight loss test). With Stability you can define tasks beyond the standard pull task like inverting, shaking and the disposal of the containers in the stability chamber.

Advanced audit features maintain complete traceability of study modifications. Included modifications include addition, deletion, and rescheduling of timepoints, replacement of storage conditions, and supplemental or reduced testing.

Boost Efficiency with Automated Stability Study Management

Stability testing often involves monitoring a product's stability over a period of many years. During the entire study duration, LABVANTAGE Stability expedites the many aspects of stability study management, resulting in consistency and increased efficiency of managing extended stability studies.

Through a simple and intuitive Excel-like interface, LABVANTAGE Stability allows you to automate:

• Shelf-life sample generation based on specified times and number of product pulls for each study
• Label creation based upon scheduled pull dates
• Calculation of the required number of containers to start a stability study
• Sample and container traceability using barcodes
• Inventory tracking by container or raw units
• Freeze-thaw cycles
• Creation of pull lists including partial sample pulls to remove test samples at defined protocol intervals

Advanced Reporting

LABVANTAGE Stability provides a variety of out-of-the-box reports that allow you to keep current throughout the stability study lifecycle and promptly react to abnormal conditions:

• Trend of analytical results per study, packaging, storage condition and test method
• Multiple studies analysis
• Shelf-life prediction
• Out-of-Trend detection
• Projected workload
• Inventory state and history

Key Benefits

• Adherence to regulations and quality standards (FDA,ICH)
• Accurate mapping and documentation of every aspect of the stability study lifecycle
• Automated, streamlined operations for increased efficiency
• Easy knowledge sharing with out-of-the-box reporting