Stability Testing Software for Pharmaceutical Industry
Stability studies are conducted in the Life Sciences industry to better understand drug product behaviour under various storage environments throughout its shelf life. Stability studies aid in ensuring the effectiveness of a product. Pharmaceutical industries place a high premium on product stability testing to confirm that they adhere to established processes and standards.
For each new drug product in the Pharmaceutical and Biotech industry, three batches of samples are reserved for stability studies (accelerated, intermediate, and long-term). Subsequently, at least one batch each year of each product is designated as an exhibit batch and is committed to Long Term Conditions. According to the ICH (Q1A) and ICDRA recommendations, a Stability procedure for each product code, and the stability conditions and intervals must be established.
The initial frequencies to be used for a long-term stability study are 3,6,9,12,18, 24, 36, and 48 months. The frequencies for Intermediate are Initial, 3, 6, 9, and 12 months. The frequency for accelerated stability must be Initial, 1, 2, 3, and 6 months. Following that, any changes in composition, manufacturing method, API source, manufacturing equipment, or batch size will necessitate new stability studies.
Stability testing’s continuance in the pharmaceutical industry indicates that it is a critical procedural element of the current pharmaceutical development program for new drugs and formulations.
Current Challenges of Stability Study in Biotech and Pharmaceutical QC Laboratory
- Large sample quantities and their frequency make managing stability schedules, tracking and maintaining the timeline a challenge.
- Stability batch schedule management by hand takes a lot of time and work, and it puts the process at risk for data integrity errors. With so many samples undergoing Stability Studies, a delay in testing is very likely. This can result in process deviations and non-compliance with the Stability Schedule.
- Data that has been manually collected may contain mistakes, resulting in data integrity problems. It also makes it more difficult for organizations to use the data to draw conclusions and make informed decisions.
- Organizations find it challenging to combine Stability Studies methods with OOS/OOT when they do manual stability testing.
- Manual stability testing approaches have been shown to miss important stability indicators including related substances, microbiological limit tests, and so on. Thus, testing processes are insufficient and inefficient.
AmpleLogic Stability Study Management and Lab Sample Tracking Software
AmpleLogic’s Stability Management Software is a comprehensive cGMP software designed to satisfy the demands of biotech, life sciences, pharmaceutical stability testing programs, and stability management.
Clients may use stability software to simplify and test their organization’s operations. Customers can specify the testing parameters for stability investigations. Other settings such as sample time points, package types, and testing methodologies may be defined to optimize the program for the company.
It records all of the settings and parameters that are used in colour research and keeps track of the available stability chambers. The module provides a collection of standard reports for reporting the stability procedure and its associated outcomes.
Stability Schedule Software is built on AmpleLogic’s LOW CODE PLATFORM and complies with 21CFR Part 11, EU Annex 11, GMP, MHRA, and other regulatory requirements.
Features of Stability Schedules Tracking Software and Sample Management Solution
Definition of the Stability Protocol:
- Allow the originator to create a unique reference number for the stability protocol.
- The Product Code, Lot Numbers, Sample Size and Specification Numbers, Storage Conditions, Withdrawal Date and Intervals, Specifications and Storage Conditions are all stated.
- Protocol review by quality assurance, research and development, and quality assurance heads.
Stability Sample Incubation, Pull Schedule and Schedule Planner
- Stability Samples particular to a batch are mapped to a specific Stability procedure.
- Before putting any samples into the stability chambers, they are all barcoded.
- After the sample has been placed in the stability chambers, the program makes a note of the incubation information and keeps track of where the samples are stored in the chambers (Rack/Tray wise).
Stability Schedule Calendar
- On the first day of every new month, a monthly schedule will be prepared for sample withdrawal. In addition to the batch number, storage condition, and expiration date, the schedule will provide withdrawal time, date of manufacture, and expiration.
- Using the Low-Code Stability Tracking software, you can create a reminder concerning the current status of sample pulls, and the color changes from green to red seven days before the scheduled pull.
- Once the sample is removed, all schedules will be removed from the calendar. In addition, the number of samples in the Stability chamber will be automatically updated.
- Automatic reminders assist you in sticking to your schedule.
Recording of Stability Sample Test Results
- The GMP Stability Management Software makes it easy for analysts to record sample information when they get it
- This information includes the product, strength, storage conditions, charging date, sample withdrawal times, and expiration date. All information is derived from the schedules, which are based on the protocol’s standards for frequency and stability.
- Customers will be able to record typical test findings such as appearance and identity by keeping elements such as enantiomeric purity by HPLC, IR, XRD, Water, Absorbance, and related substances in mind (impurity).
- You can simply integrate workflow-based data entry, review, email alerts, reminders, and escalations into the Stability test procedures with the aid of the stability software.
- OOS/OOT can be connected with the Stability Data Study Software so that you are alerted when the findings of the analysis go beyond a predefined range limit.
- The software’s connection with OOT/OOS enables users to get notifications for the same.
- Stability Protocol, Stability Initiation Protocol, and Incubation forms all have their separate flows.
- The definitions of the Stability Protocol are organized by grade level.
- Use AmpleLogic Stability Software to save and organize all of your study documents so you can conveniently access and evaluate them.
- It makes use of a Timely Audit Trail and Predefined Test Modes for quality assurance.
- Using the storage condition or batch number, stability data can be entered quickly and simply.
Stability Study Discontinuation and Destruction
- After the research is complete, the Stability Test Tracking Module assists in creating discontinuance requests. The batch number will automatically populate the auto-selection product code, name, production date, expiration date, and pack information.
- The user can specify an explanation for discontinuation and send it to QC and R&D for approval.
- The ability to remove the stability sample once it has been withdrawn from its tray in the stability chamber.
Stability Software Integrations
- It easily combines with other systems such as ERP (Enterprise resource planning) and LIMS, Document Management, and Learning Management System.
- In addition, the AmpleLogic Stability Management Software may be linked to Change Control, Planned Deviation, CAPA, and the LIR.
Stability Scheduling Software Reports
- AmpleLogic Stability Management Solution can create graphical reports to help with improved analysis, discussions, and conclusions.
- With the help of Stability Management Software, we will be able to generate some of the stability reports like product shelf life, monthly schedules of stability, stability studies comparison, pending schedules, stability status, monthly chamber usage and OOS Reports.
- The program can produce reports in tabular form and export them in PDF format.
- Final Stability Analysis Report and Trend Report for a drug substance will be generated automatically by the stability system and can be shared or show to regulatory bodies and auditors.
- Reports such as the comprehensive stability report, the monthly graphical stability report, the schedule-based testing report, the stability protocol report, and the monthly stability report can all be created easily.
Benefits of Stability Automation Software
- Stability samples are more readily traceable and organized in the storage or test sections
- It makes certain that all of the stability tests are completed on schedule
- Stability Chambers are put to good use
- Auto Generation of barcodes based on the samples
- Reports and analyses are generated more swiftly. This aids in data analysis and the formulation of proper discussions, conclusions, and choices for optimum productivity
- The AmpleLogic Pharmaceutical Stability Management Software System offers a versatile and data-driven workflow. Because of this, it adheres to SOPs while also eliminating manual processes as well as error-prone process stages, all of which minimize the likelihood of non-compliance
- When organizations use the Stability Study Management System, they can easily implement Quality Control Automation (QCA). As a result, time and resources can be better spent on drug research and development
- Laboratories may conveniently manage stability studies electronically using AmpleLogic Stability Management Software, minimizing errors and mistakes caused by the tedious paper-based methods
- Generate the shelf life projections by integrating with R-Tools
- For various Stability Study Standards, it is recognized to be the only program that offers specified test modes
- The time you spend on administrative tasks could be reduced with the use of the Stability Management module
- Having all computations in one place increases efficiency and productivity, mitigates risk, and results in considerable time saving
AmpleLogic’s Low-Code Stability Software complies with electronic record standards set by TGA, CDSCO, HEALTH CANADA, MCC, ANVISA, EMEA, SFDA, NAFDAC, MEDSAFE, MHLW, MCAZ, SWISSMEDIC, KFDA, and MoH
Other Industries that can benefits from our Stability Sample Management Software
- Medical Devices
- Contract Manufacturing
- General Manufacturing
- Food & Beverages
Please get in touch with us to learn more about how AmpleLogic Stability Testing Software may assist your organization.