Stability Schedules Management Tracking Software for Pharmaceutical Industry
In the Life Sciences Industry, Stability Studies are performed to understand drug product behaviour under different storage conditions during its shelf life. Stability Studies help in assuring the Product efficacy. Pharmaceutical Industries constantly emphasize on stability testing of their products to ensure that they conform to set procedures and standards.
Three batches of samples are kept for stability study (Accelerated, intermediate and long term) for every new drug product in the Pharmaceutical and Biotech Industry. Afterwards, a minimum of one batch per year of each product will be considered as exhibit batch and it is subjected for Long Term condition. As per the ICH (Q1A) and ICDRA guidelines a Stability protocol is maintained for each product code and the stability Conditions and Intervals must be defined.
For a Long Term stability study the frequencies to be followed as Initial are, 3,6,9,12,18, 24, 36 and 48 months. For Intermediate, the frequencies are Initial, 3, 6, 9 and 12 months. Accelerated stability must have the frequencies as Initial, 1, 2, 3 and 6 months. Subsequently any Changes in formulation, manufacturing process, Source of API, manufacturing equipment, batch Size will trigger additional Stability Studies.
The persistence of stability testing in pharmaceutical industry stands to be a key procedural component in the present pharmaceutical development program for a new drug as well as new formulation
Current Stability Study Challenges in Biotech Pharmaceutical QC Laboratory
- Managing stability schedules, tracking, and meeting the timeline is challenging due to large volumes of samples and their Frequencies.
- Manual management of the stability batch schedules requires extensive time and effort and exposes the process to data integrity issues. Since a large number of samples undergo Stability Studies, there is a possibility of delayed testing. This can lead to deviation in the process and poses the risk of non-compliance to the Stability Schedule.
- Manually prepared data may include errors leads to data Integrity Issues. It also reduces the ability of organizations to leverage the data for making informed decisions, drawing conclusions and having final discussions.
- Manual stability testing makes it difficult for organizations to integrate the Stability Studies procedures with OOS/OOT.
- It has been found that manual stability testing methods may exclude crucial parameters which indicate stability like related substances, microbial limit test, etc. This renders the testing procedures to be inadequate and inefficient.
AmpleLogic Stability Study Management & Lab Sample Tracking Software
Stability Management Software by Ample Logic is a complete cGMP software to meet the requirements of biotech, life sciences, pharmaceutical stability testing programs and stability management.
With the stability software, clients can streamline the streamline and testing processes for their organization. Customers have the option to define the testing parameters for stability studies. The software can be optimized for the organization by defining other parameters like sampling time points, package types and testing methods.
It records all the conditions and parameters under which a study is conducted and keeps track of the stability chambers available. A set of standard reports are delivered through the module for reporting of the stability protocol and its associated results.
Stability schedule software is developed on AmpleLogic’s LOW CODE PLATFORM and is Fully compliant with 21CFR Part 11, EU Annex 11, GMP, MHRA and other regulatory standards
Features of Stability Schedules Tracking Software Sample Management Solution
Stability Protocol Definition:
- Enable the initiator to create the stability Protocol with a unique reference number
- Define the Product code, Lot Numbers, Sample Size, Specification number, Storage Conditions, Date of withdrawal, Test Intervals, Specifications, Storage Conditions, Physical Parameters, Chemical Analysis and Microbial Analysis
- Review of Protocol by the QC, QA, R&D, QA HOD
Stability Sample Incubation, Pull Schedule and Schedule Planner
- Map the Stability Sample specific to a batch with specific Stability protocol
- Every Sample is barcoded before placing into stability chambers
- Record Sample Incubation details after Placed into Stability chambers. Record the Location of the samples in (Rack/Tray wise) in the chambers
Stability Schedule Calendar
- Monthly schedule will be auto generated for sample withdrawal on the 1st of every month. Batch no, Storage condition, date and Withdrawal Time, Manufacturing and Expiry date will be included in the schedule.
- The Low-Code Stability software has provision available to set up a reminder on sample pulling status and to change the color to red before 7 days of the schedule
- Schedules will be disappeared from the calendar once the sample is pulled out. It will also auto update the Quantity of samples in the Stability chamber
- Auto reminders help you follow the schedules strictly.
Stability Sample Test Results Recording
- With the help of the Stability Management Software analysts can easily record sample details when they receive it. These details include product, strength, storage conditions, charged on date, periods for pulling out the samples, and expiration date. All details are based as per the schedules which rely on the frequency and stability conditions outlined in the protocol.
- The Stability test results will help customers record typical test results like appearance, and identification by keeping factors like enantiomeric purity by HPLC, IR, XRD, Water, Absorbance, and related substances (impurity)
- With the help of the software, you can easily include workflow based data entry, review, email alerts, reminders and escalations in the Stability test processes.
- The system is integrated with OOS/OOT so that you can be notified when the analysis results exceed the pre-defined range limit.
- The integration of the software with OOT/OOS makes it possible for users to receive alerts for the same.
- Separate flows have been created for different criteria such as Stability Protocol, Stability Initiation Protocol, and Incubation forms.
- Stability Protocol Definition are arranged grade wise.
- Adopts Timely Audit Trail and Predefined test modes.
- Stability data can be entered easily based on storage condition or batch number
Stability Study Discontinuation and Destruction
- Stability Test tracking Module helps to create discontinuation requests based on the study completion. The auto selection product code, name, manufacturing date, expiry date and pack details will be auto populated according to the batch number.
- The user can fill the discontinuation reason and can send for approval to QC and R&D
- Provision available to withdraw the stability sample from the respective tray in the stability chamber for destruction
Stability Software Integrations
- It can integrate effortlessly with other systems including ERP (Enterprise resource planning) and LIMS, Document Management, and Learning Management System.
- Can also link with Change control Planned deviation, CAPA and LIR
Stability Scheduling Software Reports
- AmpleLogic Stability Management Solution can generate graphical reports for better analysis, discussions and conclusions.
- Can generate the reports in Tabular format and can also export the reports in PDF.
- Reports like Stability detailed report, Stability monthly graphical report, schedule-wise testing report, stability protocol report, and stability monthly reports can be generated easily
Benefits of Stability Automation Software
- Stability samples are better organized and easily traced from the stores or test compartments
- Ensure all stability sample pulls are performed on time
- Effective use of stability Chambers
- There is quicker generation of reports and analysis. This helps to analyze the data and make accurate discussions, conclusions and decisions for maximum output and productivity.
- AmpleLogic Pharma Stability Management Software System provides flexible and data-driven workflow. This is designed in a way that it complies with standard operating procedures, eliminates manual processes, error-prone process steps, and reduces the risk of deviations and non-compliance.
- By using the Stability Study Management System, organizations can enable better implementation of Quality Control Automation. As a result, valuable time and efforts can be redirected towards drug discovery and development.
- It is known to be the only stability testing software that provides predefined test modes of different Stability Study Standards.
- Having all calculations in a single platform improves efficiency, productivity, reduces risk and provides significant time savings.
AmpleLogic Low-Code Stability Software is in compliance with electronic Record standards defined 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