Stability studies certify the maintenance of product quality, efficacy and safety throughout the shelf life, this is considered as pre-requisite for the acceptance and endorsement of any pharmaceutical product. The persistence of stability testing in pharma industry stands to be a key procedural component in the present pharmaceutical development program for a new drug as well as new formulation.
AmpleLogic introduces Stability Management Module exclusively created for pharmaceutical firms, records all the conditions under which a study is conducted and keeps track of the stability chambers available. The stability tracking system provides complete control of stability studies for a variety of industries that includes creation of the stability protocol with its various notes, required fields and imported documents. A set of standard reports are delivered through the module for reporting of the stability protocol and its associated results.
- A single strategic platform for all quality control and assurance activities.
- Leverages industry best practices with industry and government regulations and ISO standards.
- A distinct console system to comprehensively manage product specifications and control limits.
The system manages the Stability Plan and Testing, enabling customers to define the test parameters for stability studies, including sampling time points, package types, and test methods. It is a fully Part 11 compliant, with a complete audit trail that is easy to read and search. The system is simple enough to check who corrected a typographical error and powerful enough for in-depth auditing by QA/QC. It helps to generate submission ready stability data summaries within a click of a button.
AmpleLogic Stability Module is executed either in phase wise or full version. The implementation process can be done just in 2 Weeks thru a 100% validated system with 21 CFR Part 11 Compliant.
Product Stability automation Module Features
- To check the quality of a drug substance or drug product which varies with time under the influence of a variety of environmental factors such as temperature, humidity, and light, and to establish a re-test period for the drug substance or a shelf life for the drug product and recommended storage conditions.
- Managing the increasing number of batches manually.
- In ability to evaluate and discuss stability data to provide a suitable conclusion.
- Manual stability testing cannot be integrated with OOS/OOT.
- Manual stability testing sometimes fails to include all stability indicating parameters like related substances, microbial limit test etc.
AmpleLogic Stability Schedules Management and Tracking Software Features:
- Stability Schedule Calendar helps to keep track of different schedules of the testing with reminders and escalations.
- Details like Stability Protocol Reference Number, Stability Protocol Version etc. can be maintained.
- Separate flow for each Stability Protocol, Stability Initiation Protocol and Incubation forms.
- Products Master and Templates Configuration can be done.
- Workflow based data entry, review, email alerts, reminders, and escalations.
- Grade wise Stability Protocol Definition.
- Timely Audit Trail and Predefined test modes.
- Stability data can be entered based on storage condition or batch number.
- Intuitive reports, test interval reports, schedule reports and graphical representation of analytical results.
- Stability detailed report, Stability monthly graphical report, schedule wise testing report, stability protocol report and stability monthly reports can be generated from the system for reference.
- Better traceability of different stability samples which are stored or pulled or tested.
- Quicker reports help to analyse the data and make quality decisions for maximum output in earlier decision making.
- Provides flexible data-driven workflow, that ensures compliance with standard operating procedures, eliminates manual, error-prone process steps, and reduces risk of deviations and noncompliance.
- Effective implementation of Quality Control automation reduces time efforts for drug discovery and development.
- Integrates seamlessly with other systems including ERP (Enterprise resource planning), Document Management, and Learning Management System.
- The only software which provides predefined test modes of different Stability Study Standards.
- Monitoring of quality-relevant instruments can be demonstrated to auditors during audit trial.